FDA Device recall Z-1466-2021
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access o…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access o… 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-1466-2021 |
| 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
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.
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: H787CT96STSDVI1, Lot #: 5616651, 5647359, 5654135 UPN: H787CT96STSAVI1, Lot #: 5654129 |
|---|
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 - AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of va…
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-1466-2021%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.