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Class 2 Device Recall Cryopatch SG Pulmonary Human Cardiac Patch |
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Date Initiated by Firm |
May 14, 2018 |
Create Date |
June 21, 2018 |
Recall Status1 |
Terminated 3 on March 29, 2019 |
Recall Number |
Z-2272-2018 |
Recall Event ID |
80199 |
510(K)Number |
K101866
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Product Classification |
Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
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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
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For Additional Information Contact |
770-419-3355
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DXZ and Original Applicant = CRYOLIFE, INC.
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