Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BioGlue

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BioGlue see related information
Date Initiated by Firm October 07, 2021
Create Date December 15, 2021
Recall Status1 Terminated 3 on October 23, 2023
Recall Number Z-0384-2022
Recall Event ID 88929
PMA Number P010003 
Product Classification Glue, surgical, arteries - Product Code MUQ
Product BioGlue Surgical Adhesive, Model BG3510-5-G
Code Information Model BG3510-5-G, Lot BG000255
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact
770-419-3355
Manufacturer Reason
for Recall		 Product is not approved for use in the EU and should not have been distributed in the EU.
FDA Determined
Cause 2		 No Marketing Application
Action A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm.
Quantity in Commerce 156 5-pack box units
Distribution Distribution in the European Union only (Germany/Switzerland)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MUQ and Original Applicant = CRYOLIFE, INC.
-
-