SPS Sterilization recalls resterilized Wallstent endoprosthesis stents due to expiration date exceeding validated shelf life. Affected stents may degrade over time.
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.
SPS Sterilization is recalling resterilized Boston Scientific Wallstent stents because the expiration date on the product exceeds its actual shelf life. This could lead to potential degradation of the stent over time.
The stent's expiration date on the product label is longer than the actual shelf life it can safely last after resterilization. This means the stent might degrade over time, potentially causing issues.
Patients who received the resterilized Wallstent stents with the specified lot and serial numbers are affected. Those with medical implants using this stent type are at risk.
Check for the product code 40451-R, lot number 18098774, and serial numbers 21408032017-12 or 21408032017-13 on the stent packaging.
Verify the product code, lot number, and serial numbers on the stent packaging to confirm if it is affected.
The recall is for potential degradation over time, but it does not pose an immediate risk of serious injury.
Check for the product code 40451-R, lot number 18098774, and serial numbers 21408032017-12 or 21408032017-13 on the stent packaging.
The recall does not require immediate action; check the product details to confirm if it is affected.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3036-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3036-2018 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.
