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Recall Observatory FDA recall evidence

Device product

Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

Z-1454-2017

February 27, 2017

Class II

Product summary

Firm
CORENTEC CO., LTD
Event
Event 76587
Status
Terminated
Classification
Class II
Quantity
5 ea
Official record key
device-enforcement:Z-1454-2017

Official wording

Reason: Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

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

Distribution pattern: US Distribution to the state of : PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.