B. Braun Medical Infusomat Sets: False Air Alarms May Cause Serious Injury
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.
Stop using this now
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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/56969-b-braun-medical-infusomat-sets-false-air-alarms-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/56969-b-braun-medical-infusomat-sets-false-air-alarms-may-cause · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0355-2024
Cite this page
“B. Braun Medical Infusomat Sets: False Air Alarms May Cause Serious Injury.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56969-b-braun-medical-infusomat-sets-false-air-alarms-may-cause. Based on FDA recall #Z-0355-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0355-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
B. Braun Medical- Category
Medical device
What to do — step by step
Stop Using Now
Immediately stop using the recalled Infusomat Administration Sets to prevent false alarms that could interrupt critical medication delivery.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution US nationwide, Canada and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0355-2024 (November 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0355-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.