Jelco 4285Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20351688046786), received between Feb 17, 2022 and Feb 18, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K923127); they may or may not involve this specific model.
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
- Connection Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2022Connection Problem; Connection Problem
IT WAS REPORTED THAT WHEN USING A 20G X 1" SAFETY NEEDLE TO MAKE A STERILE ADMIXTURE, THE NEEDLE ASSEMBLY CAME APART AND THE NEEDLE FLEW ACROSS THE ISOLATOR HOOD WHEN AIR WAS EXPELLED FROM THE SYRINGE. IT IS WHERE THE SMALLER HUB CONNECTS TO THE LARGER HUB WHERE THE NEEDLE CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559678 ↗MalfunctionFeb 17, 2022Connection Problem; Connection Problem
IT WAS REPORTED THAT WHEN USING A 20G X 1 " SAFETY NEEDLE TO MAKE A STERILE ADMIXTURE, THE NEEDLE ASSEMBLY CAME APART AND THE NEEDLE FLEW ACROSS THE ISOLATOR HOOD WHEN AIR WAS EXPELLED FROM THE SYRINGE. IT IS WHERE THE SMALLER HUB CONNECTS TO THE LARGER HUB WHERE THE NEEDLE CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13551673 ↗MalfunctionFeb 17, 2022Connection Problem; Connection Problem
IT WAS REPORTED THAT WHEN USING A 20G X 1 " SAFETY NEEDLE TO MAKE A STERILE ADMIXTURE, THE NEEDLE ASSEMBLY CAME APART AND THE NEEDLE FLEW ACROSS THE ISOLATOR HOOD WHEN AIR WAS EXPELLED FROM THE SYRINGE. IT IS WHERE THE SMALLER HUB CONNECTS TO THE LARGER HUB WHERE THE NEEDLE CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13551514 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K923127. One submission often covers many models, so check the product and lot details in each record.
- Z-2670-2017 · Apr 4, 2017 · TerminatedJelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.