Recall Z-0653-2021
CryoLife, Inc. · initiated November 10, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135 C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.
Codes / lots: Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485
Reason for recall
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
FDA-determined cause: Material/Component Contamination
Action taken
A Recall notification letter titled "Urgent - Voluntary Human Tissue Recall" was sent to consignees via email or hand delivered by firm representatives. On 11-Nov-2020, 4 letters were delivered to consignees. On 12-Nov-2020, 2 letters were delivered to consignees. The letter instructs the consignee to complete and return the enclosed postcard affirming that they received the notification. The affected product should be quarantined and returned to CryoLife immediately, if it has not been implanted. CryoLife Field Representatives were to provide information necessary to arrange for the return of the affected product. If the product has been implanted and the consignee has questions or requires clarification, the consignee is to contact Dr. Gregory Ray, CryloLife Medical Director at 800-438-8285.
Details
- Recall number
- Z-0653-2021
- Initiated
- November 10, 2020
- Terminated
- October 26, 2021
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Quantity
- 2 units
- Distribution
- Distributed nationwide to GA, AZ, TX, MO, and OK.
- Recalling firm
- CryoLife, Inc., Kennesaw, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0652-2021 Class II | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture…On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for… | 11/10/2020Terminated |