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Olympus Corporation of the Americas recalls Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, P
Recalled September 15, 2021 · FDA recall Z-2423-2021 · Olympus Corporation of the Americas
Hazard
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection. · FDA Class II
Units
711,157 units units
Sold at
Nationwide
Description
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
Product
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 of the endoscope to facilitate endoscopic therapy
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →