FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: 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.
- Recall number
- Z-0653-2021
- Recalling firm
- CryoLife, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-11-10
- Posted
- not on file
- Terminated
- 2021-10-26
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 2 units
- Distribution
- Distributed nationwide to GA, AZ, TX, MO, and OK.
- Lot, serial or model codes
- Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485
- 510(k) numbers
- ["K101866"]
- PMA numbers
- not on file
- Product code
- DXZ
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28