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U.S. Department of Health and Human Services

Class 2 Device Recall CryoPatch SG

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 Class 2 Recall
CryoPatch SG
see related information
Date Posted January 23, 2014
Recall Status1 Terminated on February 20, 2014
Recall Number Z-0809-2014
Recall Event ID 67182
Premarket Notification
510(K) Number
K101866 
Product Classification Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene - Product Code DXZ
Product Pulmonary Hemi-Artery SG Used in heart surgery
Code Information Serial No. 10119759, Model SGPH00
Recalling Firm/
Manufacturer
CryoLife, Inc.
1655 Roberts Blvd Nw
Kennesaw, Georgia 30144-3632
For Additional Information Contact Sandra O'Reilly
770-419-3355
Manufacturer Reason
for Recall
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
Action CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.
Quantity in Commerce One
Distribution Nationwide distribution including CA
Total Product Life Cycle TPLC Device Report

 
1 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.
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