| 2026-04-10 |
Class I
|
Ongoing |
Z-2159-2026 |
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-… |
— |
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl… |
| 2026-04-10 |
Class I
|
Ongoing |
Z-2158-2026 |
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152… |
— |
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl… |
| 2026-04-10 |
Class I
|
Ongoing |
Z-2157-2026 |
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151… |
— |
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl… |
| 2026-04-10 |
Class I
|
Ongoing |
Z-2156-2026 |
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I |
— |
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl… |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1917-2026 |
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code… |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1916-2026 |
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206… |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1915-2026 |
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531… |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1914-2026 |
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code:… |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1913-2026 |
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: … |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1912-2026 |
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)2… |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1911-2026 |
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J… |
— |
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 |
Class II
|
Ongoing |
Z-1910-2026 |
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 … |
— |
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured |
| 2024-07-26 |
Class II
|
Ongoing |
Z-3299-2024 |
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not … |
— |
Reports have been received regarding open seals on the packaging. |
| 2024-04-29 |
Class I
|
Ongoing |
Z-1880-2024 |
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U |
— |
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The … |
| 2024-04-29 |
Class I
|
Ongoing |
Z-1879-2024 |
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U |
— |
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The … |
| 2024-04-29 |
Class I
|
Ongoing |
Z-1878-2024 |
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS |
— |
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The … |
| 2024-02-12 |
Class I
|
Ongoing |
Z-1267-2024 |
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-042… |
— |
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complai… |
| 2023-08-10 |
Class II
|
Ongoing |
Z-2591-2023 |
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percut… |
— |
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| 2023-08-10 |
Class II
|
Ongoing |
Z-2590-2023 |
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular |
— |
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| 2023-08-10 |
Class I
|
Ongoing |
Z-0004-2024 |
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,… |
— |
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| 2023-08-10 |
Class I
|
Ongoing |
Z-0003-2024 |
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic,… |
— |
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| 2023-08-10 |
Class I
|
Ongoing |
Z-0002-2024 |
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intra… |
— |
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| 2023-08-10 |
Class I
|
Ongoing |
Z-0001-2024 |
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R… |
— |
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-1826-2023 |
ARROW Endurance Extended Dwell Peripheral Catheter System |
— |
Potential for catheter separation or leakage |
| 2022-10-27 |
Class I
|
Terminated |
Z-0352-2023 |
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-4… |
— |
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Cen… |
| 2022-10-27 |
Class I
|
Terminated |
Z-0351-2023 |
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer |
— |
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Cen… |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0456-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0455-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0454-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0453-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0452-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0451-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0450-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0449-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0448-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0447-2023 |
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0446-2023 |
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0445-2023 |
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0444-2023 |
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0443-2023 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0442-2023 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0441-2023 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0440-2023 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0439-2023 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0438-2023 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0437-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0436-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0435-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0434-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0433-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0432-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0431-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0430-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0429-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0428-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0427-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-10-17 |
Class I
|
Ongoing |
Z-0426-2023 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump |
— |
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| 2022-09-14 |
Class II
|
Terminated |
Z-0102-2023 |
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH… |
— |
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French cat… |
| 2022-05-05 |
Class II
|
Terminated |
Z-1290-2022 |
Arrow Three-Lumen CVC |
— |
Gravity flow rates on the affected product lidstock are incorrect. |
| 2021-09-20 |
Class I
|
Terminated |
Z-0234-2022 |
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerot… |
— |
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven… |
| 2021-09-20 |
Class I
|
Terminated |
Z-0233-2022 |
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Treroto… |
— |
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven… |
| 2021-09-20 |
Class I
|
Terminated |
Z-0232-2022 |
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trer… |
— |
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven… |
| 2021-09-20 |
Class I
|
Terminated |
Z-0231-2022 |
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerot… |
— |
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional interven… |
| 2021-05-19 |
Class II
|
Ongoing |
Z-2071-2021 |
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Produ… |
— |
Marketed without a 510K |
| 2021-05-19 |
Class II
|
Ongoing |
Z-2070-2021 |
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary u… |
— |
Marketed without a 510K |
| 2021-05-19 |
Class II
|
Ongoing |
Z-2069-2021 |
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product… |
— |
Marketed without a 510K |
| 2021-05-19 |
Class II
|
Ongoing |
Z-2068-2021 |
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for … |
— |
Marketed without a 510K |
| 2021-03-08 |
Class II
|
Ongoing |
Z-1374-2021 |
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Pr… |
— |
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is… |
| 2021-01-06 |
Class II
|
Terminated |
Z-1106-2021 |
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the fem… |
— |
The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the … |
| 2020-07-06 |
Class II
|
Terminated |
Z-2804-2020 |
NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograd… |
— |
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an… |
| 2020-07-06 |
Class II
|
Terminated |
Z-2803-2020 |
Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space. |
— |
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an… |
| 2020-07-06 |
Class II
|
Terminated |
Z-2802-2020 |
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub conn… |
— |
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an… |
| 2020-07-06 |
Class II
|
Terminated |
Z-2801-2020 |
Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits acces… |
— |
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2417-2020 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701 |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2416-2020 |
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700 |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2415-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535 |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2414-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2413-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2412-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2411-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2410-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2409-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-20 |
Class I
|
Terminated |
Z-2408-2020 |
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 |
— |
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptib… |
| 2020-05-08 |
Class II
|
Ongoing |
Z-2288-2020 |
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TA… |
— |
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. |
| 2020-01-15 |
Class II
|
Terminated |
Z-1218-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1217-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1216-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1215-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1214-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1213-2020 |
Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1212-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1211-2020 |
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1210-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1209-2020 |
FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1208-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1207-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1206-2020 |
FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1205-2020 |
10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1204-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1203-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1202-2020 |
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1201-2020 |
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1200-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1199-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1198-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1197-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1196-2020 |
FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1195-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1194-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1193-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1192-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1191-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1190-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1189-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1188-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1187-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1186-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1185-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1184-2020 |
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1183-2020 |
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1182-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1181-2020 |
Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1180-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1179-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1178-2020 |
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1177-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1176-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1175-2020 |
TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1174-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1173-2020 |
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1172-2020 |
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1171-2020 |
FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |
| 2020-01-15 |
Class II
|
Terminated |
Z-1170-2020 |
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B |
— |
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring… |