CryoLife recalls SG Pulmonary Heart Valves with microbial culture test failures in processing. Affected units have specific serial numbers and UDI codes. 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 SG Pulmonary Heart Valves due to microbial culture test failures in processing. This could pose a risk of infection or complications after implantation.
The recall is triggered by microbial culture test failures during processing. This means the valves may not be sterile, increasing the risk of infection or complications if implanted.
Patients who received the recalled CryoValve SG Pulmonary Heart Valves from CryoLife are affected. Those with specific serial numbers or UDI codes listed in the recall are at highest risk.
Check for serial numbers 11685214, 11685554, or 11682491 on the packaging. The unique device identifier (UDI) 00877234000447 also identifies affected units.
Reach out to CryoLife directly to confirm if your valve is affected and get instructions for next steps.
Microbial culture test failures occurred during processing, meaning the valves may not be sterile.
Check for serial numbers 11685214, 11685554, or 11682491 or UDI code 00877234000447 on the packaging.
The recall does not specify a stop-use instruction; contact CryoLife for details.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-0652-2021 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-0652-2021 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.
