Jelco 982312D-2Recalls & 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
- 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 15019517080988), received between Sep 1, 2017 and Sep 1, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fail-Safe Design Failure” (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 16, 2026.
Most reported problems
Device problems
- Fail-Safe Design Failure1
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.
InjurySep 1, 2017Fail-Safe Design Failure; Fail-Safe Design Failure
IT WAS REPORTED THAT A CLINICIAN RECEIVED A NEEDLE STICK WHEN USING A SAF-T WING® BLOOD COLLECTION AND INFUSION SET. CLINICIAN NOTICED THERE WAS A BURR INSIDE THAT'S CATCHING WHEN THE SAFETY DEVICE WAS ACTIVATED. MEDICAL INTERVENTION WAS REQUIRED. NO OTHER ADVERSE HEALTH OUTCOMES WERE REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6838631 ↗
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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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