Monoject 1186000444Recalls & reported problems
Cardinal Health 200, LLC · 60 mL Syringe Catheter Tip · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10192253034714), received between May 4, 2024 and Sep 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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
- Insufficient Device Problem Information3
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.
MalfunctionSep 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH A CARDINAL HEALTH MONOJET 60ML SYRINGE. WHEN THE TECH WAS IN THE PROCESS OF A FAT TRANSFER BETWEEN TWO SYRINGES, THE CATHETER TIP BROKE AND FAT SPLATTERED ALL OVER THE OR WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164754 ↗MalfunctionSep 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE SEAL IS NOT WORKING AND THE FORMULA IS COMING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164752 ↗MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED LEAKS AFTER PHARMACY PREPARATION IN THIS SYRINGE PRODUCT. THE CUSTOMER WAS USING WITH A BAXTER PRODUCT, REF # NOT PROVIDED, LOT 60349214. NO ADDITIONAL INFORMATION CAN BE REQUESTED AS THE INITIAL REPORTER DID NOT PROVIDE THEIR CONTACT DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244508 ↗
Other SYRINGE, IRRIGATING (NON DENTAL) devices
- Irrigation Syringe 0935280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)83 reports
- N/A 309620Becton, Dickinson And Company · SYRINGE, IRRIGATING (NON DENTAL)73 reports
- Irrigation Syringe 0035280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)58 reports
- MEDLINE DYND20125Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)1 recall3 reports
- NICO Fluid System NN-8015Nico Corporation · Syringe, Irrigating (Non Dental)1 recall0 reports
- Rapid Refill M00566000Boston Scientific Corporation · SYRINGE, IRRIGATING (NON DENTAL)1 recall0 reports
- MEDLINE DYND20302Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 reports
- Piston Irrigation Tray 750307C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 reports
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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