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U.S. Department of Health and Human Services

Class 2 Device Recall CryoPatch SG Pulmonary HemiArtery Patch

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  Class 2 Device Recall CryoPatch SG Pulmonary HemiArtery Patch see related information
Date Initiated by Firm November 21, 2016
Create Date April 25, 2019
Recall Status1 Terminated 3 on September 24, 2019
Recall Number Z-1219-2019
Recall Event ID 82380
510(K)Number K091626  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
Product CryoPatch SG Pulmonary Hemi-Artery Patch
Code Information Model #: SGPHOO Serial #10685466
Recalling Firm/
CryoLife, Inc.
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact
Manufacturer Reason
for Recall
The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
FDA Determined
Cause 2
Release of Material/Component prior to receiving test results
Action The firm sent the physician a letter on 11/21/2016.
Quantity in Commerce 1
Distribution Product was shipped to Texas
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.