BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
- Company
- Cryolife Inc
- Recall Initiated
- June 4, 2018
- Terminated
- February 8, 2019
- Recall Number
- Z-2556-2018
- Quantity
- 855 Total
- Firm Location
- Kennesaw, GA
Reason for Recall
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
Distribution
Distribution is to Japan
Lot / Code Info
Model Number BG3510-5-J, Lot Number 18MJX002
Root Cause
Error in labeling
Action Taken
CyroLife notified their customers on/about 06/04/2018 via Urgent - Important Product Removal letter. instructions indicated that affected pouches have been returned to CryoLife, Inc. Any questions/clarifications regarding this removal are directed to contact 800-438-8285 or by email to fieldassurance@c ryolife.com.
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