B. Braun Medical recalls Infusomat Administration Sets with tubing size/length issues that may cause false air-in-line alarms, interrupting medication therapy and risking serious injury or death.
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
B. Braun Medical is recalling certain Infusomat Administration Sets due to tubing that may be too small or too short. This can cause false alarms that stop medication delivery, potentially leading to serious injury or death for patients needing critical treatments.
The tubing in affected products may vary in size or be too short. This causes false air-in-line alarms that stop the infusion, interrupting critical medication delivery. For patients needing continuous treatment like vasopressors, this interruption could cause life-threatening complications or death.
Patients using these specific Infusomat Administration Sets for medication delivery are at risk. Healthcare providers and patients using the recalled models should stop using them immediately.
Check for product models listed in the recall: 362031-362035, 362043, 362050, 362420, 362432, 362911, 363010, 363019, 363030, 363032, 363230, 363410, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 363901, 363902, 363904, 470119, 480254, 480255, 480257, 480258, 480263, 480264, 490037, 490100, 490101, 490102, 490103, 490104, 490105. Also check for specific lot numbers listed with each model.
Immediately stop using the recalled Infusomat Administration Sets to prevent false alarms that could interrupt critical medication delivery.
The recall includes specific Infusomat Administration Sets with model numbers 362031-362035, 362043, 362050, 362420, 362432, 362911, 363010, 363019, 363030, 363032, 363230, 363410, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 363901, 363902, 363904, 470119, 480254, 480255, 480257, 480258, 480263, 480264, 490037, 490100, 490101, 490102, 490103, and 490104-490105.
Check the model number on the product label. The affected models are listed in the recall notice, including specific model numbers and lot numbers for each model.
Immediately stop using the product and contact B. Braun Medical for instructions on how to return it.
We’ve drafted a message you can send B. Braun Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0355-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-0355-2024 from B. Braun Medical. 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.
