Boston Scientific recalls Flexima Duodenal Bend Biliary Stent with Delivery System (7F) due to potential packaging seal defects. Affected units may have compromised sterility.
The sterile barrier may contain packaging seal defects.
Boston Scientific is recalling a specific type of biliary stent due to possible packaging seal defects that could compromise sterility. This means the stent might not be sterile when used, increasing infection risk during medical procedures.
The packaging seal defects could allow contaminants to enter the sterile packaging. This might lead to infection if the stent is not properly sterile when inserted into a patient during surgery.
Healthcare professionals using the recalled stent for medical procedures are most at risk. Patients receiving the stent during surgery could face infection complications.
Check for the product name 'Flexima Duodenal Bend Biliary Stent with Delivery System', size 7F (2.3mm) x10cm, and material number M00539220. The affected units were manufactured with lot number 22960202.
Identify the product by checking the material number M00539220 and lot number 22960202 on the packaging.
The recall is due to potential packaging seal defects that could compromise sterility. If the stent is not sterile when used, it may increase infection risk during surgery.
Check for the material number M00539220 and lot number 22960202 on the packaging. The product is a Flexima Duodenal Bend Biliary Stent with Delivery System, size 7F (2.3mm) x10cm.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1012-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1012-2019 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.
