Edwards Lifesciences recalls resterilized aortic perfusion cannulas due to expiration date exceeding validated shelf life. Affected units have specific serial numbers and lot codes. Contact for remedy details.
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 aortic perfusion cannulas that may have an expiration date beyond their safe shelf life. This could lead to improper sterilization and potential infection risks if used.
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 mismatch could lead to improper sterilization and potential infection risks if the cannula is used after its validated shelf life.
Healthcare professionals using these cannulas for medical procedures are most at risk. Patients receiving the cannulas could face infection if the device is not properly sterilized.
Check for serial numbers 16504192017-01 through 16504192017-10 and lot number 5973601. These units were resterilized by SPS Sterilization, Inc.
Verify the serial numbers and lot number on the cannula to confirm if it 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 serial numbers and lot number to confirm if it is affected. 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-3027-2018 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-3027-2018 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.
