Jelco 972306Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 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 00351688059973), received between Sep 18, 2018 and Sep 18, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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
- Fail-Safe Did Not Operate1
- Fail-Safe Problem1
Patient problems
- Needle Stick/Puncture1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2018Fail-Safe Problem; Fail-Safe Did Not Operate; Fail-Safe Problem; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE SAFETY MECHANISM JAMMED AS IT WAS PULLED BACK. THE OPERATOR SUFFERED A NEEDLESTICK WHILE DISPOSING OF THE SHARP INTO THE SHARPS BOX. THE OPERATOR STATED SPECIFICALLY THAT THE "TUBE HAD KINKED, THEN TURNED BACK UP, AND (THE) NEEDLE CAUGHT (THE) SIDE OF RIGHT THUMB."
Patient problems: Needle Stick/Puncture; Patient Problem/Medical Problem
MAUDE report 7887202 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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