Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Company
- Cryolife Inc
- Recall Initiated
- May 14, 2018
- Terminated
- March 29, 2019
- Recall Number
- Z-2272-2018
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
Reason for Recall
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Distribution
AR, OH
Lot / Code Info
Serial Number 10988328
Root Cause
Under Investigation by firm
Action Taken
The firm notified the consignees by letter on 05/14/2018.
More recalls by Cryolife Inc
BioGlue Surgical Adhesive, Model BG3510-5-G
Oct 7, 2021
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium con...
Nov 10, 2020
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium c...
Nov 10, 2020
On-X Aortic Heart Valve with Anatomic Sewing Ring
Product Usage:
The On-X Prosthetic Heart Valve is...
Jan 17, 2019
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Sep 6, 2018