Date Initiated by Firm |
November 25, 2002 |
Date Posted |
February 28, 2003 |
Recall Status1 |
Terminated 3 on March 21, 2003 |
Recall Number |
Z-0426-03 |
Recall Event ID |
25109 |
Product Classification |
Introducer, Catheter - Product Code DYB
|
Product |
COOK Stiffened Micropuncture¿ Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT
|
Code Information |
All lots on the market as of 11/25/2002. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way P.O. Box 489 Bloomington IN 47402-0489
|
For Additional Information Contact |
Customer Relations Department 800-457-4500
|
Manufacturer Reason for Recall |
The tip of the stiffened cannula might break during use
and remain in the patient.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand. |
Quantity in Commerce |
4,223 |
Distribution |
United States, Brazil, Canada, Dominican Republic and Israel.
|
Total Product Life Cycle |
TPLC Device Report
|
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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.
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