| 2025-04-10 |
Class I
|
Ongoing |
Z-1682-2025 |
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA… |
— |
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| 2025-04-10 |
Class I
|
Ongoing |
Z-1681-2025 |
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111… |
— |
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| 2025-04-10 |
Class I
|
Ongoing |
Z-1668-2025 |
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0… |
— |
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or dela… |
| 2025-04-10 |
Class I
|
Ongoing |
Z-1667-2025 |
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO… |
— |
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or dela… |
| 2025-04-10 |
Class I
|
Ongoing |
Z-1662-2025 |
CADD Solis HSPCA Pump |
— |
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can l… |
| 2025-02-14 |
Class II
|
Ongoing |
Z-1405-2025 |
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 |
— |
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway… |
| 2025-02-14 |
Class II
|
Ongoing |
Z-1404-2025 |
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 |
— |
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway… |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1289-2025 |
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035… |
— |
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, unde… |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1288-2025 |
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1287-2025 |
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1286-2025 |
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24 |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1285-2025 |
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1284-2025 |
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8F… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1283-2025 |
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer,… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1282-2025 |
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1281-2025 |
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., RE… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1280-2025 |
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6F… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1279-2025 |
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., R… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1278-2025 |
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer… |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2025-02-13 |
Class I
|
Ongoing |
Z-1277-2025 |
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24 |
— |
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0529-2025 |
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 |
— |
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between th… |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0528-2025 |
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP |
— |
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between th… |
| 2024-10-28 |
Class II
|
Ongoing |
Z-0527-2025 |
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP |
— |
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between th… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0205-2025 |
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0204-2025 |
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0203-2025 |
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0202-2025 |
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0201-2025 |
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0200-2025 |
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0199-2025 |
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0198-2025 |
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0197-2025 |
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0196-2025 |
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0195-2025 |
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0194-2025 |
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0193-2025 |
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0192-2025 |
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0191-2025 |
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0190-2025 |
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0189-2025 |
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0188-2025 |
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0187-2025 |
medex Arterial Kit 1/EA, Product Code REF MX7827 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0186-2025 |
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0185-2025 |
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0184-2025 |
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0183-2025 |
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0182-2025 |
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 |
— |
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d… |
| 2024-07-18 |
Class II
|
Ongoing |
Z-0147-2025 |
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS |
— |
Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-18 |
Class II
|
Ongoing |
Z-0146-2025 |
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000 |
— |
Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-18 |
Class II
|
Ongoing |
Z-0145-2025 |
smiths medical portex, Y' PIECE 15MM, REF 100/276/000 |
— |
Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-18 |
Class II
|
Ongoing |
Z-0144-2025 |
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/15… |
— |
Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-18 |
Class II
|
Ongoing |
Z-0143-2025 |
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b)… |
— |
Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-16 |
Class I
|
Ongoing |
Z-0222-2025 |
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S… |
— |
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a sh… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0466-2025 |
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CA… |
— |
The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or mo… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0018-2025 |
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0017-2025 |
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0016-2025 |
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0015-2025 |
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0014-2025 |
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0013-2025 |
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0012-2025 |
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0011-2025 |
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-26 |
Class II
|
Ongoing |
Z-0010-2025 |
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 |
— |
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. T… |
| 2024-06-07 |
Class I
|
Ongoing |
Z-3088-2024 |
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll… |
— |
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper… |
| 2024-06-07 |
Class I
|
Ongoing |
Z-3087-2024 |
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll… |
— |
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper… |
| 2024-06-07 |
Class I
|
Ongoing |
Z-3086-2024 |
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item… |
— |
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper… |
| 2024-05-31 |
Class I
|
Ongoing |
Z-3091-2024 |
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N |
— |
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators… |
| 2024-05-31 |
Class I
|
Ongoing |
Z-3090-2024 |
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N |
— |
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators… |
| 2024-05-31 |
Class I
|
Ongoing |
Z-2974-2024 |
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX |
— |
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-05-31 |
Class I
|
Ongoing |
Z-2973-2024 |
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX |
— |
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2615-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2614-2024 |
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDI… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2613-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Produ… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2612-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2611-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANG… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2610-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Cod… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2609-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANG… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2608-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2607-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Cod… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2606-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2605-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2604-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List N… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2603-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2602-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List … |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2601-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Pro… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2600-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2599-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Produ… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2598-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2597-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/Li… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2596-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2595-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List N… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2594-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List … |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2593-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO S… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2592-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/L… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2591-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2590-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2589-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2588-2024 |
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Cod… |
— |
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a… |
| 2024-02-27 |
Class I
|
Ongoing |
Z-2421-2024 |
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following u… |
— |
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, s… |
| 2024-02-27 |
Class I
|
Ongoing |
Z-2420-2024 |
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, … |
— |
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, s… |
| 2024-02-27 |
Class I
|
Ongoing |
Z-2419-2024 |
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: I… |
— |
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsi… |
| 2024-02-07 |
Class I
|
Ongoing |
Z-1275-2024 |
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS |
— |
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of… |
| 2024-02-07 |
Class I
|
Ongoing |
Z-1274-2024 |
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS |
— |
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-1543-2024 |
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 |
— |
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-1542-2024 |
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 301… |
— |
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-1541-2024 |
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5… |
— |
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-1540-2024 |
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0… |
— |
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740… |
| 2023-12-19 |
Class I
|
Ongoing |
Z-0864-2024 |
smiths medical Medfusion Model 4000 syringe pump |
— |
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Prio… |
| 2023-12-19 |
Class I
|
Ongoing |
Z-0863-2024 |
smiths medical Medfusion Model 3500 Syringe pump |
— |
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusi… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0747-2024 |
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0746-2024 |
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0745-2024 |
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0744-2024 |
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0743-2024 |
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0742-2024 |
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0741-2024 |
6IN PRESSURE TUBING, List Number MX20617 |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0740-2024 |
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-11-10 |
Class II
|
Ongoing |
Z-0739-2024 |
Medex LOGICAL CATH LAB KIT, List Number M20754 |
— |
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting se… |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0141-2024 |
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 |
— |
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifi… |
| 2023-08-22 |
Class II
|
Ongoing |
Z-0205-2024 |
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. |
— |
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration dat… |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0081-2024 |
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump |
— |
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failur… |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0080-2024 |
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump |
— |
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failur… |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0079-2024 |
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0… |
— |
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failur… |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0078-2024 |
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06… |
— |
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failur… |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0077-2024 |
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 |
— |
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failur… |
| 2023-08-16 |
Class II
|
Ongoing |
Z-0076-2024 |
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 |
— |
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failur… |
| 2023-07-18 |
Class II
|
Ongoing |
Z-2466-2023 |
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter |
— |
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1582-2023 |
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Po… |
— |
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not pro… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1581-2023 |
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elb… |
— |
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not pro… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1580-2023 |
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port f… |
— |
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not pro… |
| 2022-12-09 |
Class I
|
Ongoing |
Z-0966-2023 |
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, … |
— |
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No D… |
| 2022-12-09 |
Class I
|
Ongoing |
Z-0965-2023 |
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, … |
— |
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No D… |
| 2022-12-09 |
Class I
|
Ongoing |
Z-0964-2023 |
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP,… |
— |
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No D… |
| 2022-12-09 |
Class I
|
Ongoing |
Z-0963-2023 |
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5)… |
— |
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No D… |
| 2022-12-09 |
Class I
|
Ongoing |
Z-0962-2023 |
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 |
— |
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No D… |
| 2022-10-10 |
Class II
|
Ongoing |
Z-0272-2023 |
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump… |
— |
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump an… |
| 2022-04-18 |
Class I
|
Ongoing |
Z-1272-2022 |
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-8… |
— |
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. T… |
| 2022-04-18 |
Class I
|
Ongoing |
Z-1271-2022 |
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 40… |
— |
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. T… |
| 2021-08-09 |
Class II
|
Terminated |
Z-0178-2022 |
Bivona Uncuffed Wire Endotracheal Tubes, |
— |
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. |
| 2021-08-09 |
Class II
|
Terminated |
Z-0177-2022 |
Bivona Aire-Cuf Endotracheal Tube |
— |
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. |
| 2021-08-06 |
Class I
|
Ongoing |
Z-2377-2021 |
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700 |
— |
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| 2021-08-06 |
Class I
|
Ongoing |
Z-2376-2021 |
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 |
— |
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| 2021-08-04 |
Class II
|
Terminated |
Z-2401-2021 |
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile. |
— |
The incorrect device is contained in the package. |
| 2021-07-15 |
Class III
|
Terminated |
Z-0163-2022 |
Pneupac paraPac plus 300 ventilator kit, REF P300NGB |
— |
Two devices were labeled with the same serial number |
| 2021-05-17 |
Class I
|
Terminated |
Z-1798-2021 |
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G… |
— |
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barre… |
| 2021-05-14 |
Class II
|
Terminated |
Z-1993-2021 |
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controll… |
— |
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit. |
| 2021-03-31 |
Class II
|
Terminated |
Z-1516-2021 |
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from met… |
— |
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| 2021-03-31 |
Class II
|
Terminated |
Z-1515-2021 |
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial… |
— |
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| 2021-03-31 |
Class II
|
Terminated |
Z-1481-2021 |
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transduce… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1480-2021 |
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascul… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1479-2021 |
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Numbe… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1478-2021 |
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the directio… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1477-2021 |
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATO… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1476-2021 |
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1475-2021 |
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures. |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1474-2021 |
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to contr… |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1473-2021 |
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1472-2021 |
Left Heart Kit, Model Number M20268. for blood pressure monitoring. |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1471-2021 |
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling. |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-03-31 |
Class II
|
Terminated |
Z-1470-2021 |
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling. |
— |
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or … |
| 2021-01-18 |
Class II
|
Terminated |
Z-1145-2021 |
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 39… |
— |
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172,… |
| 2020-12-21 |
Class II
|
Terminated |
Z-0874-2021 |
Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory P… |
— |
Shipping box may contain wrong model. |
| 2020-12-15 |
Class II
|
Terminated |
Z-0726-2021 |
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 |
— |
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flan… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0152-2022 |
smiths medical portex Loss of Resistance Device, REF 100/398/000 |
— |
The labeling was missing information on sterilization and prohibition of reuse. |
| 2020-08-28 |
Class II
|
Terminated |
Z-2946-2020 |
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheo… |
— |
Label has the incorrect size for the tracheotomy tube. |
| 2020-07-14 |
Class II
|
Terminated |
Z-0148-2022 |
CADD Administration Sets, Model #21-7346-24 |
— |
Product may have been manufactured with an air filter assembled in an incorrect orientation. |
| 2020-06-26 |
Class I
|
Ongoing |
Z-2735-2020 |
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. |
— |
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| 2020-06-26 |
Class I
|
Ongoing |
Z-2734-2020 |
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 |
— |
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| 2020-06-11 |
Class II
|
Terminated |
Z-2499-2020 |
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system. |
— |
Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a… |
| 2020-05-26 |
Class II
|
Terminated |
Z-2485-2020 |
Pediatric Adjustable Flange Tracheostomy Tube Cuffless |
— |
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate. |
| 2020-03-24 |
Class I
|
Terminated |
Z-0107-2022 |
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L … |
— |
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line… |
| 2020-03-10 |
Class II
|
Terminated |
Z-0103-2022 |
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0102-2022 |
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0101-2022 |
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0100-2022 |
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0099-2022 |
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0098-2022 |
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0097-2022 |
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0096-2022 |
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0095-2022 |
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0094-2022 |
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0093-2022 |
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) … |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-03-10 |
Class II
|
Terminated |
Z-0092-2022 |
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181… |
— |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| 2020-02-28 |
Class II
|
Terminated |
Z-1820-2020 |
Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide … |
— |
Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were lab… |
| 2020-01-07 |
Class II
|
Terminated |
Z-1716-2020 |
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes |
— |
Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. |
| 2020-01-07 |
Class II
|
Terminated |
Z-1715-2020 |
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes |
— |
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. |