Recall Z-2623-2017— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2017-05-19, terminated 2019-02-08. FDA's recall record names no specific 510(k) clearance for this event. Product: BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J. Reason: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-19
- Terminated
- 2019-02-08
- Firm location
- Kennesaw, GA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.