FDAClass IIJuly 5, 2017

BioGlue Surgical Adhesive recall

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

Why was BioGlue Surgical Adhesive recalled?

The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code 17MJX002, Model/Catalog Number BG3510-5-J

Product
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Recalling firm
CryoLife, Inc.
Quantity
705 single pack boxes
Distribution
Product distributed in Japan.
Recall date
July 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls