|
Class 2 Device Recall Cook ATB Advance PTA Dilatation Catheter |
|
Date Initiated by Firm |
February 28, 2007 |
Date Posted |
March 29, 2007 |
Recall Status1 |
Terminated 3 on May 29, 2007 |
Recall Number |
Z-0665-2007 |
Recall Event ID |
37568 |
510(K)Number |
K052036
|
Product Classification |
angioplasty dilatation catheter - Product Code DQY
|
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. |
Code Information |
Lot 1820419. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
|
For Additional Information Contact |
800-346-2686
|
Manufacturer Reason for Recall |
Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via telephone on 2/28/07 and instructed to return the product. |
Quantity in Commerce |
20 units |
Distribution |
Illinois, North Carolina and South Carolina. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DQY and Original Applicant = COOK, INC.
|
|
|
|