The Recall Desk

FDA (Devices) recall action 86890

CryoLife, Inc. recalled 2 products on 2020-12-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-30
Critical
0
Units
5

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··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.

    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
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2020-12-30

    CryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures

    CryoLife, Inc. is recalling three CryoValve SG Pulmonary Human Heart Valves because post-processing microbial culture tests failed for allografts processed with the same TRIS saline solution lot.

    Product
    CryoValve SG Pulmonary Human Heart Valve. The valve 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 i
    Category
    Distribution
    5 states