FDA Enforcement
Class II
Terminated
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Recall: Z-1454-2017
·
Reported March 22, 2017
Enforcement
- Recall Number
- Z-1454-2017
- Event ID
- 76587
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CORENTEC CO., LTD
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 22, 2017
- Initiation Date
- February 27, 2017
- Classification Date
- March 13, 2017
- Termination Date
- May 11, 2017
- Address
- Seobuk-gu, 12 Yeongsanhong 1-gil, Seobuk-gu, Cheonan-si, N/A, N/A, Korea (the Republic of)
Description
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Reason
Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
Code Info
Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
Distribution
US Distribution to the state of : PA
Quantity
5 ea