Reported Sep 15, 2021 · Terminated
Arc Endocuff Vision as follows
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
Arc Endocuff Vision as follows
4 of 4 products
| Model / number | Product as published |
|---|---|
E0420501 | ARV110 ENDOCUFF-V M BLUE PK8 |
E0420500 | ARV120 ENDOCUFF-V L GREEN PK8 |
E0420502 | ARV130 ENDOCUFF-V S PURPLE PK8 |
E0420503 | ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy |
- Lot codes and dates
- Lot numbers
99 of 99 codes
607806215164141654646636560862624056426365465663676086562407642656546666634608676246964268654896663660869624716453365490666386116862473645356549166640611716278164537654966691061176627836467465497669126128562787646766549866914615786303564678654996702161580630376473865521670236158263039648316552367025
- Lot numbers
- Amount recalled
- 711,157 units units
Where it was sold
- Nationwide
Why it was recalled
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
This product could cause temporary or reversible health problems — stop using it.
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