Jelco 412558Recalls & reported problems
Icu Medical, Inc. · Class 2
- 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 20351688075502), received between Jul 21, 2017 and Jul 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Protective Measures Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Protective Measures Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY OF A JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE DIDN'T WORK, CAUSING THE NURSE TO BE STUCK BY THE NEEDLE. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6732438 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.