Boston Scientific recalls certain pancreatic stents due to incorrect shelf life labeling (36 months instead of 18 months). Affected units were sold between Sept 2017 and Sept 2019. No action is required as the product is safe but may expire sooner than intended.
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Boston Scientific is recalling pancreatic stents that were labeled with a 36-month shelf life instead of the approved 18-month shelf life. This means the stents could expire earlier than intended, but the product remains safe to use if stored properly.
The stents were labeled with a 36-month shelf life instead of the approved 18-month shelf life. This could mean the product expires earlier than intended, but the stent itself does not pose an immediate safety risk.
Patients who received the recalled stents between September 2017 and September 2019 are most at risk. The product is safe but may expire sooner than intended.
Check for the product name 'Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm' with lot numbers listed in the recall notice. The product was sold between September 2017 and September 2019.
Verify the product's shelf life label matches the approved 18-month period. If it shows 36 months, it is affected.
No, the stent is safe to use but may expire earlier than intended due to the incorrect shelf life label.
No action is required as the product is safe. The recall is for labeling accuracy, not safety.
Affected lot numbers include 21187998, 21285271, 21337147, 21483841, 21512595, 21662812, 21724126, 21833852, 21922988, 22036149, 22136471, 22307745, 22359735, 22613955, 22700891, 23035017, 23295961, 23492660, 23541961, 24006978, 24271828, 24383293, 24411526.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0552-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0552-2020 from Boston Scientific. 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.
