Summary
The FDA issued a Class II for CryoValve SG Cryopreserved Pulmonary Human Heart Valve by Artivion, Inc. Reason: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus..
Details
Source
Device Recall
External ID
Z-1545-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Lot/Code Info: Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Quantity Affected: 1 unit
Reason for Recall
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Distribution
US Nationwide distribution in the state of Ohio.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-06
Company
Kennesaw, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Artivion, Inc has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Artivion, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Artivion, Inc have FDA actions?
Artivion, Inc has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1545-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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