Cook Inc. recalls Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; C
Recalled Product
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; 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.
Hazard / Issue
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Issued by
FDA
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