Jelco 326800Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10351688077851), received between Apr 2, 2018 and Apr 2, 2018 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (10 reports).
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
- Manufacturing, Packaging or Shipping Problem10
Patient problems
- No Consequences Or Impact To Patient10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389942 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389935 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389932 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389931 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389930 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389928 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389927 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389923 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389921 ↗MalfunctionApr 2, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS WHITE WITH NO ORANGE STRIP. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7389919 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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