FDA Device recall Z-0377-2016
AMS 4675 Angio Pack
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of AMS 4675 Angio Pack by Windstone Medical Packaging, citing AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0377-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-02 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Windstone Medical Packaging |
| Distribution | AL, VA |
Product
AMS 4675 Angio Pack. For use in a general clinical procedure.
Reason
AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
Identifiers
| code_info | Lot 84371, expiration date: 2/28/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0377-2016%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.