FDA Medical Device Recalls (openFDA)
CORENTEC CO., LTD: Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
- Recall number
- Z-1454-2017
- Recalling firm
- CORENTEC CO., LTD
- Product
- Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
- Status
- Terminated
- Initiated
- 2017-02-27
- Posted
- 2017-03-13
- Terminated
- 2017-05-11
- Reason
- Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
- Root cause
- Other
- Action
- 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
- Quantity
- 5 ea
- Distribution
- US Distribution to the state of : PA
- Lot, serial or model codes
- Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
- 510(k) numbers
- ["K162127"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3009106092
- Firm city
- Seobuk-gu
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28