Reported Jun 27, 2018 · Terminated
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
CryoLife, 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: CryoLife, Inc. · 1655 Roberts Blvd NW · Kennesaw, GA · 30144-3632
Is this the product you have?
- Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
- Lot codes and dates
- Serial Number 10988203
- Amount recalled
- 1 unit
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
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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