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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve Allograft

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  Class 2 Device Recall CryoValve Allograft see related information
Date Initiated by Firm February 18, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on July 21, 2003
Recall Number Z-0673-03
Recall Event ID 25635
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Allograft, heart valve
Code Information Donor #61266, Serial # 7701969, Model #AV00; Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, Model #PV00.
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Shari L. Allen
770-419-3355
Manufacturer Reason
for Recall		 Microorganisms were detected in distributed donor tissue.
FDA Determined
Cause 2		 Other
Action Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.
Quantity in Commerce There were six (6) individual heart valve allografts.
Distribution Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.
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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