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U.S. Department of Health and Human Services

Class 2 Device Recall COOK Stiffened Micropuncture Introducer Set

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  Class 2 Device Recall COOK Stiffened Micropuncture Introducer Set see related information
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
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.
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.
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