AMS 4675 Angio Pack — Class II medical device recall Z-0377-2016
Terminated recall by Windstone Medical Packaging, Inc., reported 2015-12-16, distributed in AL, VA. AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which
| Recall number | Z-0377-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2015-11-02 |
| Classified | 2015-12-04 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-08-17 |
| Distributed | AL, VA |
| Quantity | 40 kits |
| Lot numbers | 84371 |
| Expiration dates | 2017-02-28 |
Product
AMS 4675 Angio Pack. For use in a general clinical procedure.
Reason for recall
AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0377-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.