Medical device recalls Moderate risk

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

Recall date
February 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1454-2017
FDA classification
Class II
Brand / firm
CORENTEC CO., LTD
Sold / distributed
US Distribution to the state of : PA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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