Edwards Lifesciences recalls resterilized Thin-Flex Single Stage Venous Drainage Cannulas with expired labeling due to sterilization process limitations. 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 Thin-Flex Single Stage Venous Drainage Cannulas because the expiration date on the device labeling exceeds its actual validated shelf life. This issue arises from the sterilization process not supporting extended shelf life, which could lead to potential safety concerns if the cannula is used beyond its safe period.
The sterilization process used for these cannulas does not adequately support extended shelf life, causing the expiration date on the device labeling to exceed its actual safe period. This could potentially lead to safety issues if the cannula is used after its validated shelf life has expired.
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 serial numbers 18302172017-01 through 18302172017-10 and lot number 59634935 on the cannula packaging. The product is a resterilized Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, model 38FRX40CM.
Verify the serial numbers and lot number on the cannula packaging 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 extended shelf life.
Check the serial numbers and lot number on the packaging to see if it is affected. If it is, contact Edwards Lifesciences for further instructions.
The recall is due to labeling expiration issues, not an immediate risk of serious injury. The hazard level is low risk.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-3029-2018 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-3029-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
