Home / Recalls / CORENTEC CO., LTD / Z-1454-2017

Z-1454-2017 Class II Terminated

Recalled by CORENTEC CO., LTD — Seobuk-gu, Cheonan-si, N/A

FDA device recall Z-1454-2017 was initiated by CORENTEC CO., LTD on Feb 27, 2017 and is designated Class II. Reason for recall: Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. The recall status is terminated (terminated May 11, 2017). Affected quantity: 5 ea.

Recall details

Product Type: Devices
Report Date: Mar 22, 2017
Initiation Date: Feb 27, 2017
Termination Date: May 11, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5 ea

Product description

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.

Distribution pattern

US Distribution to the state of : PA

Code information

Lot Number: 10AFFQ21 Expiration Date: 2021-11-28

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1454-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.