Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
FDA device recall Z-1454-2017 · posted 2017-03-13 · Terminated
Recall details
- Recalling firm
- CORENTEC CO., LTD
- Reason for recall
- Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
- Action taken
- Corentec sent an Medical Device Recall letter dated February 23, 2017. The recalling firm notified the consignee via written notification by email and by phone. The recalled products will be returned to the recalling firm. For further questions please call (512) 327-9997
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 5 ea
- Distribution
- US Distribution to the state of : PA
- Date initiated
- 2017-02-27
- Date posted
- 2017-03-13
- Date terminated
- 2017-05-11
- Location
- Seobuk-gu
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Bencox M Stem Lateralized & Bencox Mirabo Cup System (K162127) | Corentec Co., Ltd. | 2016-12-05 |