CryoLife recalls CryoPatch SG Pulmonary Cardiac Patches due to microbial culture test failures in some batches. Affected units have specific model numbers and serials. Consumers should contact CryoLife for details.
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.
CryoLife is recalling certain CryoPatch SG Pulmonary Human Cardiac Patches because some batches failed microbial culture tests. This could pose a risk of infection during medical procedures if the patch is used without proper testing.
The patches were processed using a TRIS saline solution lot that failed microbial culture tests. This means the patches might not be sterile, increasing the risk of infection during medical procedures.
Patients who received the recalled CryoPatch SG Pulmonary Cardiac Patches from the specific model numbers and serials listed. Medical professionals using these patches for surgeries are at risk if they use the affected units.
Check for model number SGP020 and serial numbers 11677186, 11679112, or 11681763. The product is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
Reach out to CryoLife directly to confirm if your specific patch is affected and get instructions for next steps.
The recall is due to microbial culture test failures in some batches of the TRIS saline solution used during processing.
The affected model number is SGP020 with serial numbers 11677186, 11679112, and 11681763.
Check for the model number SGP020 and the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-0653-2021 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-0653-2021 from CryoLife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
