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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-0165-05
Recall Event ID 30218
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Pulmonary Valve & Conduit
Code Information Donor #40003, Serial #6528309, Model #PV00* Donor #40017, Serial #6528244, Model #PV00* Donor #41194, Serial #6575765, Model #PV00*  Donor #41205, Serial #6575951, Model #PV00* Donor #41983, Serial #6601316, Model #PV00* Donor #45463, Serial #6708282, Model #PV00*  Donor #45539, Serial #6697697, Model #PV00*  Donor #45616, Serial #6735116, Model #PV00*  Donor #46477, Serial #6741538, Model #PV00* Donor #46894, Serial #6768760, Model #PV00*  Donor #49793, Serial #6888973, Model #PV00*  Donor #50045, Serial #7110175, Model #PV00*  Donor #50982, Serial #7004457, Model #PV00*  Donor #50986, Serial #7048353, Model #PV00* Donor #51902, Serial #7037079, Model #PV00*  Donor #59101, Serial #7387145, Model #PV00* Donor #61954, Serial #7682701, Model #PV00 
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 17 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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