CryoLife, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1219-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

CryoPatch SG Pulmonary Hemi-Artery Patch

Product Classification:

Class II

Date Initiated: November 21, 2016

Date Posted: May 1, 2019

Recall Number: Z-1219-2019

Event ID: 82380

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.

Status: Terminated

Product Quantity: 1

Code Information:

Model #: SGPHOO Serial #10685466

Distribution Pattern:

Product was shipped to Texas

Voluntary or Mandated:

Voluntary: Firm initiated