B. Braun recalls 100-unit cartons of ULTRASITE US04TL Smallbore T-Port Extension Sets (Product Code 474515) due to high failure risk causing leaks, detachment, bloodstream infections, and potential life-threatening issues.
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
B. Braun is recalling 100 units per carton of ULTRASITE US04TL Smallbore T-Port Extension Sets because they can leak or detach during use, leading to infections and serious health risks. This affects IV therapy equipment used in healthcare settings.
The extension set has a high probability of failing at the bonded joint during use, which can cause leaks or detachment. This may delay therapy, increase the risk of bloodstream infections, and expose patients and healthcare workers to hazardous medications. In severe cases, it could lead to life-threatening conditions like air embolization or hypovolemia.
Healthcare professionals and patients using IV therapy equipment with this specific extension set are at risk. Those with the Product Code 474515 and carton numbers listed in the recall are most affected.
Check for the Product Code 474515 on the carton. The recall includes 100 units per carton with specific lot numbers and expiration dates listed in the recall notice.
Immediately stop using the ULTRASITE US04TL Smallbore T-Port Extension Set if it is part of the recall.
The extension set has a high probability of failure at the bonded joint during use, which could lead to leaks, detachment, bloodstream infections, and life-threatening situations.
The Product Code for the recalled items is 474515.
100 units per carton are affected by this recall.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-0090-2023 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-0090-2023 from B. Braun. 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.
