Edwards Lifesciences recalls resterilized 20F X 55CM femoral venous 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 femoral venous cannulas that may have an expiration date beyond their safe shelf life. This could lead to potential safety 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 safety issues if the cannula is used after the validated shelf life ends.
Healthcare professionals using the cannulas for medical procedures are most at risk. Patients receiving these cannulas during treatment may be affected if the device is used after the expiration date.
Check for the code number VFEM020-R, lot number 59691447, and serial number 16704032017-01 on the device. These identifiers are specific to the recalled units.
Look for the code number VFEM020-R, lot number 59691447, and serial number 16704032017-01 on the device.
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 labels for the code number VFEM020-R, lot number 59691447, and serial number 16704032017-01. If you have these identifiers, contact Edwards Lifesciences for further instructions.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3033-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3033-2018 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.
