Class 2 Device Recall Cryopatch SG Pulmonary Human Cardiac Patch

• Date Initiated by Firm: May 14, 2018
• Create Date: June 21, 2018
• Recall Status: Terminated on March 29, 2019
• Recall Number: Z-2272-2018
• Recall Event ID: 80199
• 510(K)Number: K101866
• Product Classification: Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
• Product: Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
• Code Information: Serial Number 10988328
• 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: 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 = DXZ and Original Applicant = CRYOLIFE, INC.