Class II — CORENTEC CO., LTD
| Recalling firm | Corentec Co., Ltd. |
|---|---|
| Registered facility | CORENTEC CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. |
| Product | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 |
| Quantity | 5 ea |
| Distribution | US Distribution to the state of : PA |
| Initiated | 2017-02-27 |
| Classified | 2017-03-13 |
| Terminated | 2017-05-11 |
| Recall number | Z-1454-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CORENTEC CO., LTD (Z-1454-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76587/
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