Pulmonary Hemi-Artery SG Used in heart surgery
FDA device recall Z-0809-2014 · posted 2014-01-23 · Terminated
Recall details
- Recalling firm
- CryoLife, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- One
- Distribution
- US distribution in CA.
- Date initiated
- 2013-11-22
- Date posted
- 2014-01-23
- Date terminated
- 2014-02-20
- Location
- Kennesaw, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866) | Cryolife, Inc. | 2010-07-23 |