Date Initiated by Firm |
November 21, 2016 |
Create Date |
April 25, 2019 |
Recall Status1 |
Terminated 3 on September 24, 2019 |
Recall Number |
Z-1219-2019 |
Recall Event ID |
82380 |
510(K)Number |
K091626
|
Product Classification |
Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
|
Product |
CryoPatch SG Pulmonary Hemi-Artery Patch |
Code Information |
Model #: SGPHOO Serial #10685466 |
Recalling Firm/ Manufacturer |
CryoLife, Inc. 1655 Roberts Blvd Nw Kennesaw GA 30144-3632
|
For Additional Information Contact |
770-419-3355
|
Manufacturer Reason for Recall |
The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
|
FDA Determined Cause 2 |
Release of Material/Component prior to receiving test results |
Action |
The firm sent the physician a letter on 11/21/2016. |
Quantity in Commerce |
1 |
Distribution |
Product was shipped to Texas |
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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