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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 06, 2004
Date Posted November 03, 2004
Recall Status1 Terminated 3 on June 29, 2010
Recall Number Z-0166-05
Recall Event ID 30218
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Aortic Valve & Conduit
Code Information Donor #25741, Serial #6048048, Model #PV00* Donor #34696, Serial #6356176, Model #PV00* Donor #40017, Serial #6528252, Model #AV00* Donor #41180, Serial #6575609, Model #AV00* Donor #41204, Serial #6575862, Model #AV00* Donor #41737, Serial #6593488, Model #AV00*  Donor #45446, Serial #6714974, Model #AV00*  Donor #45592, Serial #6735875, Model #AV00* Donor #46183, Serial #6736590, Model #AV00*  Donor #46484, Serial #6774373, Model #AV00*  Donor #46505, Serial #6770996, Model #AV00* Donor #47518, Serial #6761788, Model #AV00* Donor #50045, Serial #7110160, Model #AV00*  Donor #50098, Serial #7106597, Model #AV00*  Donor #50953, Serial #7000596, Model #AV00*  Donor #50982, Serial #7090443, Model #AV00*  Donor #53789, Serial #7013389, Model #AV00* Donor #54935, Serial #7235057, Model #AV00*  Donor #59111, Serial #7343716, Model #AV00* Donor #59407, Serial #7322607, Model #AV00 
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Mr. P. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall		 CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about May 6, 2004.
Quantity in Commerce 20 units
Distribution Nationwide, Austria, Canada, Germany
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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