Medline Industries, Inc. LC385Recalls & reported problems
Medline Industries, Inc. · SINGLE LUMEN TUBING CHANGE KIT · Class 2
Data updated Oct 18, 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 10193489466577), received between Jul 2, 2024 and Jul 2, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER ON (B)(6), "THE NURSE CHANGED THE INFANT'S CENTRAL LINE IV FLUIDS. THE NURSE PRIMED ALL LINES ATTACHED TO THE EQUIPMENT GIVEN AND ALL LINES FLUSHED EASILY. IV FLUIDS WERE CLEAR FLUIDS. THE NURSE COMPLETED ALL STERILE PROCEDURE STEPS TO COMPLETE UMBILICAL VEIN CENTRAL LINE. THE NURSE CONNECTED PRIMED IV TUBING TO UVC AND STARTED CHARTING. AFTER 5 MINUTES, THE INFUSION PUMP ALARMED THAT THERE WAS AIR IN THE LINE. THE NURSE PROCEEDED TO TRACE LINES TO FIND THE SOURCE OF THE AIR, BUT NO AIR BUBBLES WERE IN THE LINE. THE NURSE NOTICED THE BED WAS LEAKING WITH BLOOD AT THE END OF THE IV TUBING.".
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19656021 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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