BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- Company
- Cryolife Inc
- Recall Initiated
- May 19, 2017
- Terminated
- February 8, 2019
- Recall Number
- Z-2623-2017
- Quantity
- 705 single pack boxes
- Firm Location
- Kennesaw, GA
Reason for Recall
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Distribution
Product distributed in Japan.
Lot / Code Info
Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
Root 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.
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