CARESAFE™ 354304Recalls & reported problems
B. Braun Medical Inc. · CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955259960), received between Nov 16, 2023 and Nov 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (1 report).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
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-0623-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Free or Unrestricted Flow1
- Inaccurate Flow Rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2023Inaccurate Flow Rate; Free or Unrestricted Flow; Inaccurate Flow Rate; Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: ROLLER CLAMP IS NOT WORKING PROPERLY. DETAILED INQUIRY DESCRIPTION: WE HAD ISSUES WITH CONTROLLING THE RATE OF FLOW WITH THE ROLLERBALL. IT HAD TO BASICALLY BE CLOSED TO REDUCE THE DRIP RATE MAKING IT DIFFICULT TO TITRATE THE FLOW. MANY PATIENTS RECEIVED ALMOST THE ENTIRE LITER OF FLUID BEFORE REACHING THE OR EVEN WHEN THE NURSES FELT THEY HAD ADEQUATELY CLOSED THE ROLLERBALL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18151034 ↗
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
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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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