Reported Oct 24, 2018 · Terminated
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
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?
- CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Lot codes and dates
Model Number SGPH00Serial Number 10978889Lot Number 144125Expiration Date 05/16/2022
- Amount recalled
- 1 graft
Where it was sold
- Nationwide
- CA
Why it was recalled
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
This product could cause temporary or reversible health problems — stop using it.
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