Edwards Lifesciences Optisite Arterial Perfusion Cannula (22F X 2:4cm) with expired sterilization date may not be safe. Recall covers specific 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 certain Optisite Arterial Perfusion Cannulas due to a labeling error that shows an expiration date beyond the actual safe shelf life after resterilization. This could lead to unsafe use if the cannula is used after its validated shelf life ends.
The sterilization process used does not support the extended shelf life claimed on the device. This means the expiration date on the labeling is incorrect and the cannula may not be safe for use after its validated shelf life ends.
Healthcare professionals using the specific model and lot numbers listed in the recall notice are most at risk. Patients using these cannulas are not directly affected by the recall.
Check for the model 'Optisite Arterial Perfusion Cannula, 22F X 24CM' with lot number 59637295 and serial number 16502032017-01. The product was resterilized.
Verify the lot number (59637295) and serial number (16502032017-01) 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.
The recall notice does not specify a remedy, so check the product details to see if it matches the listed lot and serial numbers.
The product may not be safe for use after its validated shelf life ends due to the labeling error.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3034-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3034-2018 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.
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.
