Bencox Mirabo PE Liner 36/44 Model Number: H1 — Class II medical device recall Z-1454-2017
Terminated recall by CORENTEC CO., LTD, reported 2017-03-22. Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions fo
| Recall number | Z-1454-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CORENTEC CO., LTD, Seobuk-gu, Cheonan-si, N/A, Korea (the Republic of) |
| Recall initiated | 2017-02-27 |
| Classified | 2017-03-13 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-05-11 |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 08806373852343 |
| Lot numbers | 10AFFQ21 |
| Model numbers | H1.L61.3644 |
| Expiration dates | 2021-11-28 |
Product
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Reason for recall
Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
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-1454-2017. 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.