Edwards Lifesciences recalls resterilized 18FR femoral venous cannulas due to expiration date exceeding validated shelf life. Affected units have specific code and lot 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 femoral venous cannulas that may have an expiration date beyond their safe shelf life. This could lead to device failure during medical procedures if used after the validated shelf life expires.
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 device failure during medical procedures if used after the validated shelf life expires.
Healthcare professionals using the cannulas for medical procedures are most at risk. Patients receiving these cannulas during surgery may be affected if the device fails due to expiration.
Check for code number VFEM018-R, lot number 59740463, and serial number 16704192017-01 on the device packaging or label.
Look for code number VFEM018-R, lot number 59740463, and serial number 16704192017-01 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 code number VFEM018-R, lot number 59740463, and serial number 16704192017-01. If you have these numbers, contact Edwards Lifesciences for further instructions.
The recall is due to potential device failure if used after the validated shelf life expires, but the hazard level is low risk as the remedy does not require immediate stop-use.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3032-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3032-2018 from SPS Sterilization. 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.
