Z-1219-2019 Class II Terminated
FDA device recall Z-1219-2019 was initiated by CryoLife, Inc. on November 21, 2016 and is designated Class II. 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. The recall status is terminated (terminated September 24, 2019). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- November 21, 2016
- Termination Date
- September 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
CryoPatch SG Pulmonary Hemi-Artery Patch
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 Pattern
Product was shipped to Texas
Code Information
Model #: SGPHOO Serial #10685466