FDA Device recall Z-1467-2021
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of va…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of va… by Angiodynamics Navilyst Medical, citing angioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1467-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-22 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
Product
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Reason
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
Identifiers
| code_info | UPN: VI10, Lot #: DP-11759 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Angiodynamics Navilyst Medical
- Xcela PICC with PASV Valve Technology/Kit 5 F-55cm
FDA Device · Class II · 2021-10-06 · Angiodynamics Navilyst Medical - Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access o…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical - XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical - BIOFLO 8F SINGLE PLASTIC FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical - BIOFLO 8F SINGLE TITANIUM NON- FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
All Angiodynamics Navilyst Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1467-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.