Reported Jul 19, 2017 · Terminated
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native…
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 Product UsageIndicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
- Lot codes and dates
Serial #'s: 46222104587605474147047507144622025473772247377264632012423772546161124520208452070946320134771217477100547814144782107478213247651184750707450871745254174520719477130247713024771210475131547414064616313478141647713054737922452071145088044508807471210847651194765106458771245254154622315462212647712054001123477120247809144741412471790446717654587194622225and 4731908
- Amount recalled
- 52
Where it was sold
Why it was recalled
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
This product could cause temporary or reversible health problems — stop using it.
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