BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Reported: July 5, 2017 Initiated: May 19, 2017 #Z-2623-2017
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.
Details
- Recalling Firm
- CryoLife, Inc.
- Units Affected
- 705 single pack boxes
- Distribution
- Product distributed in Japan.
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J. Recalled by CryoLife, Inc.. Units affected: 705 single pack boxes.
Why was this product recalled? ▼
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2017. Severity: Moderate. Recall number: Z-2623-2017.
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