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 SG Cryopreserved Pulmonary Human Heart Valve

  • 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 CryoValve SG Cryopreserved Pulmonary Human Heart Valve see related information
Date Initiated by Firm March 06, 2024
Date Posted April 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1545-2024
Recall Event ID 94250
510(K)Number K092021  
Product Classification Heart valve, more than minimally manipulated allograft - Product Code OHA
Product CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Code Information Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Recalling Firm/
Manufacturer		 Artivion, Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact
678-290-4531
Manufacturer Reason
for Recall		 The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
FDA Determined
Cause 2		 Under Investigation by firm
Action The single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of Ohio.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OHA and Original Applicant = CRYOLIFE, INC.
-
-