Reported May 2, 2018 · Terminated
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0;…
Cook Inc.
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: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter | |
| 2 | Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0 | |
| 3 | 1082700252264710827002522524 | UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
- Lot codes and dates
- Catalog numberPTA5-35-135-6-2 .0 lot 8429883
- Catalog numberPTA5-35-135-4-4.0 lot 8426883
- Amount recalled
- 40 total products
Where it was sold
Why it was recalled
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
This product could cause temporary or reversible health problems — stop using it.
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