FDA recall Z-2623-2017
CryoLife, Inc. · Class II · device
Product
BioGlue Surgical Adhesive, 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.
Distribution
Product distributed in Japan.
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-19
- Report date
- 2017-07-05
- Termination date
- 2019-02-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kennesaw, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2623-2017