FDAFDA · Food and drugs·Recall number Z-2623-2017
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Published July 5, 2017 · Recall initiated: May 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CryoLife, Inc.
- Distributor
- Product distributed in Japan.
- Lot
- Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.