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.
|