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U.S. Department of Health and Human Services

Class 2 Device Recall Cryovalve(R) SG Pulmonary Human Heart Valve

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  Class 2 Device Recall Cryovalve(R) SG Pulmonary Human Heart Valve 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-2271-2018
Recall Event ID 80199
510(K)Number K092021  
Product Classification Heart valve, more than minimally manipulated allograft - Product Code OHA
Product Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Code Information Serial Number 10988203
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
For Additional Information Contact
770-419-3355
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 = OHA and Original Applicant = CRYOLIFE, INC.
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