—#50809

Product

Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052036
Affected lot / code info: Lot 1820419.

Why it was recalled

Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via telephone on 2/28/07 and instructed to return the product.

Recalling firm

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

Distribution

Distribution pattern: Illinois, North Carolina and South Carolina.

Timeline

Recall initiated: 2007-02-28
Posted by FDA: 2007-03-29
Terminated: 2007-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.