Device product

CryoPatch SG Pulmonary Hemi-Artery Patch

Z-1219-2019

November 21, 2016

Class II

Product summary

Firm: CryoLife, Inc.
Event: Event 82380
Status: Terminated
Classification: Class II
Quantity: 1
Official record key: device-enforcement:Z-1219-2019

Official wording

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.

Code information: Model #: SGPHOO Serial #10685466

Distribution pattern: Product was shipped to Texas

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.