Reported Sep 13, 2017 · Terminated
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased,…
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?
- On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
- Lot codes and dates
Model No. ONXAAPSerial No. 3260716371830231901133194122 and 3634902
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
This product could cause temporary or reversible health problems — stop using it.
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