Reported Jan 29, 2014 · Terminated
Pulmonary Hemi-Artery SG Used in heart surgery
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?
- Pulmonary Hemi-Artery SG Used in heart surgery
- Lot codes and dates
Serial No. 10119759Model SGPH00
- Amount recalled
- One
Where it was sold
Why it was recalled
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
This product could cause temporary or reversible health problems — stop using it.
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