Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-0665-2007 · Posted 2007-03-29

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2007-02-28
Date Terminated2007-05-29
Product Quantity20 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

Illinois, North Carolina and South Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052036ATB ADVANCE PTA DILATATION CATHETERCook, Inc. · 2005-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑