BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C — Class II medical device recall Z-2284-2024
Ongoing recall by American Contract Systems Inc, reported 2024-07-17, distributed nationwide. Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual l
| Recall number | Z-2284-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc, Tiffin, OH, United States |
| Recall initiated | 2024-05-15 |
| Classified | 2024-07-05 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 552 units |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 00191072200518 |
| Lot numbers | 639231, 928241 |
| Model numbers | BPKN15C |
Product
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
Reason for recall
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
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-2284-2024. 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.