CryoLife, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0809-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Pulmonary Hemi-Artery SG Used in heart surgery

Product Classification:

Class II

Date Initiated: November 22, 2013

Date Posted: January 29, 2014

Recall Number: Z-0809-2014

Event ID: 67182

Reason for Recall:

Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

Status: Terminated

Product Quantity: One

Code Information:

Serial No. 10119759, Model SGPH00

Distribution Pattern:

US distribution in CA.

Voluntary or Mandated:

Voluntary: Firm initiated