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CryoPatch SG Pulmonary Human Cardiac Patch. The patch is… recallZ-0653-2021 · CryoLife, Inc. · initiated Nov 10, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CryoLife, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Material/Component Contamination

What the company is doing

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.

Recall details

Recall number
Z-0653-2021
Status
Terminated
Initiated by the company
Nov 10, 2020
Recalling firm
CryoLife, Inc.
Quantity
2 units
Product code
DXZ
FDA submissions
K101866
Distribution
Distributed nationwide to GA, AZ, TX, MO, and OK.

Product description

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.

Code information (models, lots, serial numbers)

Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K101866 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 86890).

Sources and updates

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