Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CryoValvesee related information
Date Initiated by FirmMay 05, 2003
Date PostedJuly 10, 2003
Recall Status1 Terminated 3 on July 10, 2003
Recall NumberZ-0988-03
Recall Event ID 26319
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve Allograft, Aortic Valve & Conduit
Code Information Donor #66810, Device Serial #8100262, Model #AV00
FEI Number 3001451326
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information ContactShari L. Allen
770-419-3355
Manufacturer Reason
for Recall		Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.
FDA Determined
Cause 2		Other
ActionThe hospital was notified by letter on 5/05/2003.
Quantity in Commerce1 unit
DistributionUnit was distributed to one hospital in CA.
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.
-
-