CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Company
- Cryolife Inc
- Recall Initiated
- September 6, 2018
- Terminated
- March 3, 2020
- Recall Number
- Z-0121-2019
- Quantity
- 1 graft
- Firm Location
- Kennesaw, GA
Reason for Recall
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.
Distribution
US Nationwide in the state of California.
Lot / Code Info
Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
Root Cause
Labeling mix-ups
Action Taken
A formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation.
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