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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm July 01, 2003
Date Posted July 29, 2003
Recall Status1 Terminated 3 on November 13, 2003
Recall Number Z-1057-03
Recall Event ID 26631
Product Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300.
Code Information All units distributed from February 24, 2003 through June 26, 2003.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Customer Relations
800-457-4500
Manufacturer Reason
for Recall		 Vial contains less product than is declared on the label.
FDA Determined
Cause 2		 Other
Action A recall letter dated July 1, 2003 was sent to all customers receiving product during the recall time period asking for a return of the product.
Quantity in Commerce 2250
Distribution United States, Australia, Brazil, Canada, Denmark, Hong Kong, India, Israel, Japan and Taiwan.
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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