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U.S. Department of Health and Human Services

Class 2 Device Recall Cryopatch SG Pulmonary Human Cardiac Patch

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  Class 2 Device Recall Cryopatch SG Pulmonary Human Cardiac Patch see related information
Date Initiated by Firm May 14, 2018
Create Date June 21, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-2272-2018
Recall Event ID 80199
510(K)Number K101866  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
Product Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
Code Information Serial Number 10988328
Recalling Firm/
CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
For Additional Information Contact
Manufacturer Reason
for Recall
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm notified the consignees by letter on 05/14/2018.
Quantity in Commerce 1 unit
Distribution AR, OH
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.
510(K) Database 510(K)s with Product Code = DXZ and Original Applicant = CRYOLIFE, INC.