Edwards Lifesciences recalls resterilized EZ Glide Aortic Cannulas (24F x 37.6CM) due to expiration date exceeding validated shelf life. Affected units have specific serial numbers 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 EZ Glide Aortic Cannulas because the expiration date on the device labeling exceeds its actual validated shelf life. This could lead to potential safety issues if the cannula degrades before use.
The sterilization process used does not support the extended shelf life, meaning the expiration date on the device labeling is longer than the actual time the product remains safe. This mismatch could cause the cannula to degrade before use, potentially leading to complications during medical procedures.
Healthcare professionals using the cannulas for medical procedures are most likely affected. Patients receiving these cannulas during surgery may be at risk if the device degrades prematurely.
Check for the product name 'Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM' with the code number EZC24A-R and lot number 59634962. Affected units have specific serial numbers listed in the recall notice.
Verify the product name, code number, lot number, and serial numbers to confirm if your device is affected.
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 product details to confirm if your device is affected. If it is, contact Edwards Lifesciences for further instructions.
The product could degrade prematurely, potentially leading to complications during medical procedures if the device is used before its actual shelf life ends.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-3028-2018 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-3028-2018 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.
