Edwards Lifesciences recalls resterilized thin-flex venous drainage cannulas due to expiration date exceeding validated shelf life. Affected units have specific serial numbers and lot codes.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Edwards Lifesciences is recalling resterilized thin-flex venous drainage cannulas that may have an expiration date beyond their safe shelf life. This could lead to potential issues if used after the validated shelf life ends.
The sterilization process used does not support the extended shelf life, causing the expiration date on the device to exceed its actual safe period. This could lead to potential issues if the cannula is used after the validated shelf life ends.
Healthcare professionals using these cannulas for venous drainage procedures are most at risk. Patients receiving these cannulas through medical facilities may also be affected.
Check for serial numbers 18304192017-12 through 18304192017-16 and lot number 59739865 on the product packaging. The product is a resterilized thin-flex venous drainage cannula with specific size and length.
Verify the serial numbers and lot number on the cannula packaging to confirm if it is affected.
The sterilization process used does not have adequate support for the extended shelf life, causing the expiration date to exceed the validated shelf life.
Check the serial numbers and lot number on the packaging to see if it is affected. If it is, contact Edwards Lifesciences for further instructions.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-3030-2018 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-3030-2018 from Edwards Lifesciences. 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.
