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U.S. Department of Health and Human Services

Class 2 Device Recall CryoPatch SG

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  Class 2 Device Recall CryoPatch SG see related information
Date Initiated by Firm November 22, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on February 20, 2014
Recall Number Z-0809-2014
Recall Event ID 67182
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 GA 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.
FDA Determined
Cause 2		 Other
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 US distribution in CA.
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.
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