Date Initiated by Firm | November 22, 2013 |
Date Posted | January 23, 2014 |
Recall Status1 |
Terminated 3 on February 20, 2014 |
Recall Number | Z-0809-2014 |
Recall Event ID |
67182 |
510(K)Number | K101866 |
Product Classification |
Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
|
Product | Pulmonary Hemi-Artery SG
Used in heart surgery |
Code Information |
Serial No. 10119759, Model SGPH00 |
Recalling Firm/ Manufacturer |
CryoLife, Inc. 1655 Roberts Blvd Nw Kennesaw GA 30144-3632
|
For Additional Information Contact | Sandra O'Reilly 770-419-3355 |
Manufacturer Reason for Recall | Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death. |
FDA Determined Cause 2 | Other |
Action | CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285.
For questions regarding this recall call 770-419-3355. |
Quantity in Commerce | One |
Distribution | US distribution in CA. |
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
|