AMS — Class II medical device recall Z-0069-2018
Terminated recall by Windstone Medical Packaging, Inc., reported 2017-11-15. Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently rec
| Recall number | Z-0069-2018 |
|---|---|
| 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 | 2017-10-24 |
| Classified | 2017-11-07 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2018-07-02 |
| Quantity | 60 kits |
| Reason classes | sterility |
| Lot numbers | 109138 |
Product
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Reason for recall
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
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-0069-2018. 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.