Infusomat® 480254Recalls & reported problems
B. Braun Medical Inc. · (15 drops/mL) Universal spike, pinch clamp, pressure limited check valve, four CARESITE® injection sites, 92 in., 61 in., 41 in.,6 in. above distal end, free flow protection clamp, backcheck valve, roller clamp, slide clamp, SPIN-LOCK® connector. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046955324798), received between Apr 6, 2022 and May 23, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (2 reports).
3 FDA recall records name this device's identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0640-2026 · Root cause: Process control · FDA record ↗
- Jun 17, 2024Open, Classified
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Z-2394-2024 · Root cause: Process control · FDA record ↗
- Nov 1, 2023Open, Classified
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.
Z-0355-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: LUER END/SPIN LOCK CRACKED, LEADING TO DISLODGEMENT AND CHEMO SPILL NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16982552 ↗MalfunctionNov 4, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE NORMAL IV TUBING WAS MADE OR PUT TOGETHER BACKWARDS. THE WHOTE CASSETTE FILTER AND GREEN CLAMP THAT GO INTO THE PUMP WERE INVERTED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15733370 ↗MalfunctionApr 6, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE GREEN ANTI-FREE FLOW PROTECTION CLAMP WAS INCORRECTLY PLACED ON THE SET. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14030653 ↗
Other Set, administration, intravascular devices
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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