Jelco 972312Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00351688059980), received between Aug 28, 2017 and May 8, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Protective Measures Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Protective Measures Problem2
- Detachment of Device or Device Component1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED FROM THE USER FACILITY: "ANOTHER MEMBER OF STAFF HAS HAD A SIMILAR NEAR-MISS EVENT THIS WEEK WHEN AGAIN IN THE PROCESS OF REMOVING THE CELLOPHANE SLEEVE, THE CAP OF THE NEEDLE DISLODGED." THE DEFECTIVE DEVICE IS NOT AVAILABLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19273703 ↗InjuryAug 28, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT A NURSE WAS SEEN IN THE EMERGENCY DEPARTMENT AFTER BEING STUCK BY THE NEEDLE OF A JELCO® SAF-T WING® BLOOD COLLECTION. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6824953 ↗InjuryAug 28, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY DEVICE OF A JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET WAS "STIFF", AND DIFFICULT TO RETRACT. THE NEEDLE WASN'T COMPLETELY RETRACTED INTO THE SAFETY AND THE NURSE WAS STUCK. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6824877 ↗
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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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