Recall Z-2623-2017
CryoLife, Inc. · initiated May 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Codes / lots: Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
Reason for recall
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
FDA-determined cause: Labeling mix-ups
Action taken
Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.
Details
- Recall number
- Z-2623-2017
- Initiated
- May 19, 2017
- Terminated
- February 8, 2019
- Product code
- MUQ – Glue, Surgical, Arteries
- Quantity
- 705 single pack boxes
- Distribution
- Product distributed in Japan.
- Recalling firm
- CryoLife, Inc., Kennesaw, GA