Medex MX448HL60Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Medex (98)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688507426), received between May 10, 2019 and May 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2019Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL INFUSION EXTENSION SET WAS IN USE IN THE NICU, IT WAS NOTED TO BE LEAKING AT THE CONNECTION. IT WAS NOTED TO BE ABOUT 8 CM X 10 CM AREA. A PIV WAS PLACED, AS WELL AS LABS DRAWN FOR COMPLETE BLOOD COUNT. HEMATOCRIT WAS REPORTED TO HAVE DROPPED FROM 42 TO 30, AND RED BLOOD CELLS WERE ORDERED TO BE TRANSFUSED. THE PHARMACY WAS NOTIFIED TO SEND STAT TOTAL PARENTAL NUTRITION FOR PIV.
Patient problems: Blood Loss
MAUDE report 8601171 ↗
Other Tubing, fluid delivery devices
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- Medex MX43660Icu Medical, Inc. · Tubing, fluid delivery27 reports
- Medex MX43860Icu Medical, Inc. · Tubing, fluid delivery13 reports
- Medex MX451FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- Medex MX452FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- Medex MX450FLIcu Medical, Inc. · Tubing, fluid delivery3 reports
- 10 in. (25 cm) Q2 Checkmate extension set 9545Quest Medical Inc · Tubing, Fluid Delivery3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page