| Class 2 Device Recall Cryopatch SG Pulmonary Human Cardiac Patch | |
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 |
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 |
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 |
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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
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