Jelco 96000SRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20351688074680), received between Aug 31, 2022 and Dec 3, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Failure to Obtain Sample2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Failure to Obtain Sample; Failure to Obtain Sample
IT WAS REPORTED THAT MULTIPLE VACUTAINERS WERE NOT WORKING AS THEY SHOULD, LABS NOT DRAWING WHEN USING VACUTAINER. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT INJURY OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705104 ↗MalfunctionDec 3, 2025Failure to Obtain Sample; Failure to Obtain Sample
IT WAS REPORTED THAT MULTIPLE VACUTAINERS WERE NOT WORKING AS THEY SHOULD, LABS NOT DRAWING WHEN USING VACUTAINER. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT INJURY OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704982 ↗InjurySep 8, 2025Break; Break
IT WAS REPORTED THAT, WHILE IN USE TO COLLECT BLOOD, THE DEVICE WAS ATTACHED TO A PERIPHERALLY INSERTED CENTRAL CATHETER LINE, AND WHEN THE CONNECTING THE PIECE INTO THE LUMEN IT BROKE OF AND WAS STUCK IN THE PATIENT'S CENTRAL VENOUS CATHETER LUMEN. THERE WAS REPORTED PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 22992283 ↗MalfunctionAug 31, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE MALE POTION OF THE VACUTAINER BROKE OFF IN THE HUB WHILE OBTAINING BLOOD CULTURE FROM A PERMCATH. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327004 ↗
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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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