Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhe: Expiration date on device labeling exceeds validated shelf life due to sterilization process. Recalled units include specific codes and serial 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.
Boston Scientific's Wallstent RP stent (8mm x 80mm) is recalled because the expiration date on its labeling exceeds the actual validated shelf life. This issue arises from the sterilization process not supporting extended shelf life. The recall is for safety, though the risk of serious injury is not specified in the record.
The sterilization process used does not provide adequate support for the stent's extended shelf life. This means the expiration date on the device labeling is longer than the actual shelf life, potentially leading to safety issues over time.
Patients who received the recalled stent (8mm x 80mm) from Boston Scientific. Those with the specific lot and serial numbers listed in the recall are most at risk.
Check for the product code 71130-R, lot number 17401915, and serial numbers 21408032017-01 or 21408032017-02. The stent is 8mm x 80mm and sold as a resterilized unit.
Review the product code, lot number, and serial numbers listed in the recall to confirm if your stent is affected.
The expiration date on the device labeling exceeds the actual validated shelf life because the sterilization process does not have adequate support for extended shelf life.
The recall record does not specify a remedy, so check the product details to see if your stent is affected.
Look for the product code 71130-R, lot number 17401915, and serial numbers 21408032017-01 or 21408032017-02.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3039-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3039-2018 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.
