CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Reported: October 24, 2018 Initiated: September 6, 2018 #Z-0121-2019
Product Description
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
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.
Details
- Recalling Firm
- CryoLife, Inc.
- Units Affected
- 1 graft
- Distribution
- US Nationwide in the state of California.
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
CryoPatch SG Pulmonary Hemi-Artery, 1 graft. Recalled by CryoLife, Inc.. Units affected: 1 graft.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0121-2019.
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