Cook Inc. recalls Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; U

Recalled May 2, 2018 · FDA recall Z-1521-2018 · Cook

Hazard

Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa. · FDA Class II

Units

40 total products

Sold at

Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru

Description

Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.

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.

Manufacturer(s)

Cook Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →