Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duoden: Stents with expired sterilization labels may degrade. Recalled due to shelf life mismatch after resterilization.
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.
Boston Scientific's Wallstent stents (22mm x 90mm) that were resterilized have a labeling expiration date that exceeds their actual shelf life. This means the stents could degrade over time, potentially causing complications if used.
The stents were resterilized using a process that doesn't support extended shelf life. This causes the expiration date on the device to be longer than the actual safe period, increasing the chance of degradation over time.
Patients who received these specific stents during resterilization processes. The risk is low as the issue relates to labeling expiration rather than immediate failure.
Check for the product name 'Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent', size 22MM x 90MM, and resterilized labels. Look for specific lot numbers: 17252887 (serial 16211282016-02) or 17465176 (serials 97403172017-16, 97403172017-40).
Look for the lot numbers 17252887 (serial 16211282016-02) or 17465176 (serials 97403172017-16, 97403172017-40) on the device.
The stents were resterilized using a process that doesn't support extended shelf life, causing the expiration date on the device to exceed its actual safe period.
Check for the product name 'Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent', size 22MM x 90MM, and resterilized labels with specific lot numbers: 17252887 (serial 16211282016-02) or 17465176 (serials 97403172017-16, 97403172017-40).
The recall record does not specify a remedy, so no action is required beyond checking the labels for the specific lot numbers.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3038-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3038-2018 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.
