CryoLife recalls On-X Aortic Heart Valve with incorrect serial number labeling. Affected units have model ONXANE-23, lot 6827216. No immediate action needed as mislabeling does not affect safety.
On-X Valve was mislabeled with the incorrect serial number.
CryoLife is recalling On-X Aortic Heart Valves with incorrect serial numbers. This mislabeling does not pose a safety risk to users and does not require immediate action.
The valve was mislabeled with the wrong serial number. This labeling error does not cause physical harm or affect device function. The recall is for record-keeping purposes only.
Patients with On-X Aortic Heart Valves (model ONXANE-23, lot 6827216) are affected. The mislabeling does not impact device safety.
Check if your valve has model ONXANE-23 and lot number 6827216. The product was sold with an expiration date of 11/19/2024.
Verify your valve's serial number matches the recalled model ONXANE-23 and lot 6827216.
No, the mislabeled serial number does not pose a safety risk to users.
No action is needed as the mislabeling does not affect device safety.
Check your valve's serial number against the recalled model ONXANE-23 and lot 6827216. No action is required.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-1073-2019 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-1073-2019 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.
