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 FirmFebruary 24, 2003
Date PostedApril 10, 2003
Recall Status1 Terminated 3 on July 23, 2004
Recall NumberZ-0719-03
Recall Event ID 25819
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve Allograft, Heart valve.
Code Information Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #PV00
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		Pre-processing cultures detected certain microorganisms in donor tissue.
FDA Determined
Cause 2		Other
ActionConsignees were first notified by telephone on 2/24/2003 with follow up letter on March 6, 2003 and were advised, if the tissue had not yet been implanted, to remove tissue from implantable inventory and place it into quarantine. CryoLife will provide specific instructions for returning the tissue. A stamped, self-addressed postcard was provided to confirm receipt of the notice and to provide information regarding the disposition of the tissue.
Quantity in Commerce2 individual heart valve allografts.
DistributionHeart allografts were distributed to two hospitals in OH and Quebec, Canada.
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.
-
-