Z-1454-2017 Class II Terminated
FDA device recall Z-1454-2017 was initiated by CORENTEC CO., LTD on February 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
- March 22, 2017
- Initiation Date
- February 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