Summary
The FDA issued a Class II for BioGlue Surgical Adhesive, Model BG3510-5-G by CryoLife, Inc.. Reason: Product is not approved for use in the EU and should not have been distributed in the EU..
Details
Source
Device Recall
External ID
Z-0384-2022
Action Date
2021-12-22
Status
Terminated
Category
device
Product Description
BioGlue Surgical Adhesive, Model BG3510-5-G
Lot/Code Info: Model BG3510-5-G, Lot BG000255
Quantity Affected: 156 5-pack box units
Reason for Recall
Product is not approved for use in the EU and should not have been distributed in the EU.
Distribution
Distribution in the European Union only (Germany/Switzerland)
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-07
Company
Kennesaw, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CryoLife, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CryoLife, Inc. have FDA actions?
This is the only FDA action we have on record for CryoLife, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0384-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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