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FDAAugust 3, 2021device

Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

What to do

FDA enforcement status: Terminated

Brands named

olympus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end... — Recall Details · AllClear