CryoPatch SG Pulmonary Hemi-Artery Patch
- Company
- Cryolife Inc
- Recall Initiated
- November 21, 2016
- Terminated
- September 24, 2019
- Recall Number
- Z-1219-2019
- Quantity
- 1
- Firm Location
- Kennesaw, GA
Reason for Recall
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.
Distribution
Product was shipped to Texas
Lot / Code Info
Model #: SGPHOO Serial #10685466
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
The firm sent the physician a letter on 11/21/2016.
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