FDA Recall
Terminated
CryoPatch SG Pulmonary Hemi-Artery Patch
Recall: Z-1219-2019
·
Initiated November 21, 2016
Recall
- Recall Number
- Z-1219-2019
- Event Number
- 82380
- Firm
- CryoLife, Inc.
- FEI Number
- 3001451326
- Product Code
- DXZ
- Status
- Terminated
- Root Cause
- Release of Material/Component prior to receiving test results
- Initiated
- November 21, 2016
- Terminated
- September 24, 2019
- Address
- 1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632
Description
CryoPatch SG Pulmonary Hemi-Artery Patch
Reason
The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
Action
The firm sent the physician a letter on 11/21/2016.
Distribution
Product was shipped to Texas
Quantity
1