FDA-Device2021-09-15Class II
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
Olympus Corporation of the Americas
Hazard
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
Sold states
Nationwide
Affected count
711,157 units units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2021Don't want to check this manually?
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