Edwards Lifesciences recalls resterilized Avid Dual Stage Venous Drainage Cannulas due to expiration date exceeding validated shelf life. Affected units have specific codes and serial numbers.
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 Avid Dual Stage Venous Drainage Cannulas because the expiration date on the label is longer than the actual shelf life the sterilization process supports. This could lead to the device becoming ineffective or unsafe after the expiration date.
The sterilization process used does not support the extended shelf life claimed on the device. This means the expiration date on the label may be longer than the actual time the device remains safe and effective after sterilization.
Healthcare professionals using the cannulas for venous drainage procedures are most at risk. Patients receiving these cannulas through medical facilities may also be affected.
Check for the code number TF293702-R, lot number 59655659, and serial numbers 18304192017-02 through 18304192017-06 on the device packaging or label.
Look for the code number TF293702-R, lot number 59655659, and serial numbers 18304192017-02 through 18304192017-06 on the device packaging or label.
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.
Check the device label for the code number TF293702-R, lot number 59655659, and serial numbers 18304192017-02 through 18304192017-06. If it matches, contact Edwards Lifesciences for further instructions.
The recall is due to potential device ineffectiveness after the expiration date, not an immediate risk of injury. The hazard is low risk as it relates to shelf life and not direct harm.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-3031-2018 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-3031-2018 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.
