CryoValve, Alt Pulmonary Valve
This recall has been terminated (originally issued November 30, 2005).
- Company
- Cryolife Inc
- Recall Initiated
- November 19, 2003
- Posted
- November 30, 2005
- Terminated
- July 2, 2009
- Recall Number
- Z-0211-06
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
Distribution
AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.
Lot / Code Info
Donor #29892, Serial #6202748, Model #PV15
Root Cause
Other
Action Taken
Consignees were notified by letter starting 11/17/2003.
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