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U.S. Department of Health and Human Services

Class 2 Device Recall Human tissue for transplantation.

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 Class 2 Device Recall Human tissue for transplantation.see related information
Date Initiated by FirmAugust 20, 2002
Date PostedMarch 26, 2003
Recall Status1 Terminated 3 on April 08, 2003
Recall NumberZ-0677-03
Recall Event ID 25493
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductOne heart and pericardium from donor 12144.
Code Information Donor # 12144.
Recalling Firm/
Manufacturer		 DCI Donor Services Tissue Services Division
1714 Hayes Street
Nashville TN 37203
Manufacturer Reason
for Recall		Human tissue was procured from donor using non-sterile instruments.
FDA Determined
Cause 2		Other
ActionConsignee was notified by memorandum on 8/20/2002.
Quantity in CommerceOne heart and pericardium.
DistributionGA
Total Product Life CycleTPLC 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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