CryoLife, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0121-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

Product Classification:

Class II

Date Initiated: September 6, 2018

Date Posted: October 24, 2018

Recall Number: Z-0121-2019

Event ID: 81095

Reason for Recall:

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

Status: Terminated

Product Quantity: 1 graft

Code Information:

Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022

Distribution Pattern:

US Nationwide in the state of California.

Voluntary or Mandated:

Voluntary: Firm initiated