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U.S. Department of Health and Human Services

Class 2 Device Recall CryoPatch SG Pulmonary HemiArtery

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 Class 2 Device Recall CryoPatch SG Pulmonary HemiArterysee related information
Date Initiated by FirmSeptember 06, 2018
Create DateOctober 18, 2018
Recall Status1 Terminated 3 on March 03, 2020
Recall NumberZ-0121-2019
Recall Event ID 81095
510(K)NumberK091626 
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
ProductCryoPatch SG Pulmonary Hemi-Artery, 1 graft
Code Information Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
FEI Number 3001451326
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact
770-419-3355
Manufacturer Reason
for Recall		The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
FDA Determined
Cause 2		Labeling mix-ups
ActionA formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation.
Quantity in Commerce1 graft
DistributionUS Nationwide in the state of California.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXZ
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