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 FirmJune 17, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 07, 2005
Recall NumberZ-1057-04
Recall Event ID 29451
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve Pulmonary Valve and Conduit
Code Information Donor Number: 64208, Serial Number: 7887057, Model Number: SGPV00, Donor Number: 64222, Serial Number: 7894333, Model Number: SGPV00 and Donor Number: 64224, Serial Number: 7894298, Model Number: SGPV00
FEI Number 3001451326
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information ContactMr. P. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall		The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on 06/17/2004 and 06/18/2004.
Quantity in Commerce3 unit
DistributionCA, OH, OR, PA.
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.
-
-