—#163783

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K091527
Affected lot / code info: Catalog number: PTA5-35-135-6-2 .0 lot 8429883; Catalog number: PTA5-35-135-4-4.0 lot 8426883

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

On April 16, 2018 Cook Medical Inc. mailed an Urgent Medical Device recall notification to affected customers. Customers were instructed to: 1) Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products; 2) Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited; 3) Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com); 4) Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com Cook Incorporated

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2018-04-16
Terminated: 2019-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163783. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.