Recall Z-0809-2014— CryoLife, Inc.

Name: FDA recall Z-0809-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-22

Class II · Terminated

Class II FDA medical device recall by CryoLife, Inc., initiated 2013-11-22, terminated 2014-02-20. It names one FDA 510(k) clearance: K101866. Product: Pulmonary Hemi-Artery SG Used in heart surgery. Reason: 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..

Recalling firm: CryoLife, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-22
Terminated: 2014-02-20
Firm location: Kennesaw, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHCryolife, Inc.·cleared 2010-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Pulmonary Hemi-Artery SG Used in heart surgery

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.