Date Initiated by Firm | November 25, 2002 |
Date Posted | February 28, 2003 |
Recall Status1 |
Terminated 3 on March 21, 2003 |
Recall Number | Z-0430-03 |
Recall Event ID |
25109 |
Product Classification |
Introducer, Catheter - Product Code DYB
|
Product | COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC |
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
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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 | 7,306 |
Distribution | United States, Brazil, Canada, Dominican Republic and Israel.
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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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