Boston Scientific recalls pancreatic stents with incorrect 36-month shelf life label instead of approved 18-month. Affected units sold between Sept 2017-2019. No action needed per recall.
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 labeling error means the stents could expire longer than intended, potentially affecting safety and effectiveness.
The stents were labeled with a 36-month shelf life instead of the approved 18-month shelf life. This error could mean the stents expire longer than intended, potentially affecting safety and effectiveness if used beyond their intended timeframe.
Patients who received the recalled stents between September 2017 and September 2019. Medical professionals using these stents for pancreatic procedures are most at risk.
Check for the UPN: M00536710 and lot numbers 21750674, 22036150, 22647191, or 23902873. The stents were sold between September 2017 and September 2019.
Look for the UPN code M00536710 and specific lot numbers listed in the recall notice.
No action is required per the recall notice. The labeling error does not pose an immediate safety risk.
The stents were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
The stents were manufactured between September 29, 2017 and September 12, 2019.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0558-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0558-2020 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.
