Cordis recalls S.M.A.R.T. Flex Biliary Stent Systems with potential cracked luer hubs that could cause leaks or dislodgement during medical procedures.
Potential for cracked luer hubs
Cordis is recalling certain S.M.A.R.T. Flex Biliary Stent Systems due to a risk of cracked luer hubs. This could lead to leaks or dislodgement during medical procedures, potentially causing complications for patients needing biliary stent treatments.
Cracked luer hubs can cause leaks or dislodgement of the stent during medical procedures. This may lead to complications such as infection or improper treatment of biliary strictures.
Patients undergoing biliary stent procedures who use the recalled S.M.A.R.T. Flex Biliary Stent Systems are most at risk. Healthcare providers using the specific model numbers listed in the recall are also affected.
Check for the product model codes (SF05100MB, SF06100MB, etc.) and lot numbers (41316, 41352, etc.) listed in the recall notice. The product is sold under the Cordis S.M.A.R.T. Flex Biliary Stent System name.
Review the model code and lot number on the product to see if it matches the recalled items listed in the notice.
Reach out to Cordis Corporation for assistance with the recall process if you have the recalled product.
The hazard is potential for cracked luer hubs, which could cause leaks or dislodgement during medical procedures.
The affected model numbers include SF05100MB, SF06100MB, SF06120MB, SF06150MB, SF07080MB, SF07100MB, SF07150MB, SF08100MB, SF08120MB, SF09030MB, SF09030SB, SF09060MB, SF09060SB, SF09080MB, SF09080SB, SF09100SB, SF10040SB, SF10060SB, and SF10080SB.
Check the model code and lot number on the product against the list provided in the recall notice.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0324-2018 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0324-2018 from Cordis. 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.
