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
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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.
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PMA Database |
PMAs with Product Code = MUQ and Original Applicant = CRYOLIFE, INC.
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