Reported Apr 24, 2024 · Ongoing
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Artivion, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Artivion, Inc · 1655 Roberts Blvd Nw · Kennesaw, GA · 30144-3632
Is this the product you have?
- CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Lot codes and dates
- Model/Catalog NumberSGPV00
- Serial ID Number12578856
- UDI-DI Number
00877234000447Expiration Date 04/05/2028
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- OH
Why it was recalled
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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