The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0653-2021·Announced 2020-12-30

CryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units

CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the recall is driven by confirmed microbial culture test failures, which represents a significant risk of infection or injury.

Plain-English summary

CryoLife, Inc. is recalling two units of the CryoPatch SG Pulmonary Human Cardiac Patch. The recall was initiated after it was discovered on November 10, 2020, that post-processing microbial culture tests failed for other allografts processed using a specific TRIS saline solution lot. This same saline solution lot was used in the processing of the recalled CryoPatch SG units.

The affected product is a cryopreserved human cardiac patch distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. The specific units involved are identified by Model/Catalog Number SGP020 and Serial Numbers 11677186, 11679112, and 11681763. The UDI for the product is 00877234000485.

The recalled units were distributed nationwide to facilities in Georgia, Arizona, Texas, Missouri, and Oklahoma. Healthcare providers and facilities should check their inventory for these specific serial numbers and contact the recalling firm for instructions on how to handle the affected units.

The recalled product

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…
Manufacturer
CryoLife, Inc.
Category
Medical Device — Cardiac Patch
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by CryoLife, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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