| 2026-03-03 |
Class II
|
Ongoing |
Z-1875-2026 |
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; … |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1874-2026 |
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM;… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1873-2026 |
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1872-2026 |
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; … |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1871-2026 |
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/U… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1870-2026 |
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Produ… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1869-2026 |
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401;… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1868-2026 |
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; … |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1867-2026 |
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 107… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1866-2026 |
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1865-2026 |
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Prod… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1864-2026 |
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Prod… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1863-2026 |
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Pro… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1862-2026 |
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/U… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1861-2026 |
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Produ… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1860-2026 |
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Prod… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1859-2026 |
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1858-2026 |
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Produ… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1857-2026 |
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2026-03-03 |
Class II
|
Ongoing |
Z-1856-2026 |
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Produc… |
— |
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath… |
| 2025-02-04 |
Class II
|
Ongoing |
Z-1391-2025 |
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60; |
— |
Product is mislabeled with the incorrect fill volume. |
| 2024-11-25 |
Class II
|
Ongoing |
Z-0770-2025 |
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 |
— |
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activatio… |
| 2024-06-18 |
Class II
|
Ongoing |
Z-2454-2024 |
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701 |
— |
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different mo… |
| 2024-06-18 |
Class II
|
Ongoing |
Z-2453-2024 |
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702 |
— |
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different mo… |
| 2024-05-21 |
Class II
|
Ongoing |
Z-2267-2024 |
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100 |
— |
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but… |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1774-2024 |
BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for … |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1773-2024 |
DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1772-2024 |
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo… |
— |
XXX |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1771-2024 |
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hem… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1770-2024 |
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1769-2024 |
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1768-2024 |
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1767-2024 |
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1766-2024 |
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031 |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1765-2024 |
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1764-2024 |
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1763-2024 |
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and … |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1762-2024 |
DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and A… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1761-2024 |
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodial… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-03-18 |
Class II
|
Ongoing |
Z-1760-2024 |
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apher… |
— |
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1348-2024 |
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1347-2024 |
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1346-2024 |
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1345-2024 |
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the va… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1344-2024 |
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into th… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1343-2024 |
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into … |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1342-2024 |
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire int… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1341-2024 |
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the … |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1340-2024 |
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the … |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1339-2024 |
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756 |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1338-2024 |
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the v… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1337-2024 |
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the … |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1336-2024 |
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the … |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1335-2024 |
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2024-01-30 |
Class II
|
Ongoing |
Z-1334-2024 |
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va… |
— |
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th… |
| 2023-12-18 |
Class II
|
Ongoing |
Z-1010-2024 |
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1… |
— |
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| 2023-03-02 |
Class II
|
Ongoing |
Z-1381-2023 |
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number… |
— |
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the Nano… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0132-2023 |
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central v… |
— |
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for th… |
| 2022-08-10 |
Class II
|
Ongoing |
Z-1819-2022 |
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). F… |
— |
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, includ… |
| 2021-07-20 |
Class II
|
Terminated |
Z-2439-2021 |
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 |
— |
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during… |
| 2021-07-20 |
Class II
|
Terminated |
Z-2438-2021 |
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D |
— |
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during… |
| 2021-07-20 |
Class II
|
Terminated |
Z-2437-2021 |
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US |
— |
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during… |
| 2021-07-20 |
Class II
|
Terminated |
Z-2437-2021 |
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US |
— |
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during… |
| 2021-07-20 |
Class II
|
Terminated |
Z-2436-2021 |
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD |
— |
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during… |
| 2020-10-14 |
Class II
|
Terminated |
Z-0418-2021 |
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter int… |
— |
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component |
| 2020-05-04 |
Class II
|
Terminated |
Z-2398-2020 |
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral… |
— |
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. |
| 2020-05-04 |
Class II
|
Terminated |
Z-2397-2020 |
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to t… |
— |
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. |
| 2020-05-04 |
Class II
|
Terminated |
Z-2396-2020 |
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnos… |
— |
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. |
| 2020-05-04 |
Class II
|
Terminated |
Z-2395-2020 |
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous… |
— |
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. |
| 2020-04-24 |
Class II
|
Terminated |
Z-0073-2022 |
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single… |
— |
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. |