Jelco 4237Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20351688048834), received between Mar 6, 2017 and Jun 24, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Physical Resistance/Sticking1
Patient problems
- Missed Dose1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE NEEDLE GOT STUCK IN THE PATIENT'S LEG. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593683 ↗MalfunctionMar 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A HYPODERMIC NEEDLE-PRO® NEEDLE DETACHED DURING HEPARIN ADMINISTRATION TO A PATIENT. IT WAS NOTED THAT THE SYRINGE DISENGAGED PRIOR TO MEDICATION ADMINISTRATION, AND THE MEDICATION WAS NOT SUCCESSFULLY ADMINISTERED. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Missed Dose
MAUDE report 6381526 ↗
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.
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.