Cardinal Health 60mlRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 06971564466257), received between Apr 13, 2024 and Apr 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K190502); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 28, 2023Class IOpen, Classified

   The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

   Z-0850-2024 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THEY HAVE IDENTIFIED THAT THE CARDINAL HEALTH MONOJECT 60ML ENTERAL SYRINGES ARE NOT IDENTIFIED AS MONOJECT SYRINGES IN THE FEEDING PUMPS AND THEREFORE CANNOT DELIVER FEEDS TO BABIES. THIS IS CURRENTLY THE ONLY LOT NUMBER AVAILABLE TO US TO TEST, BUT 100% OF THOSE TESTED HAVE FAILED USING MULTIPLE PUMPS AND PUMP SETTINGS. WE HAVE NOT EXPERIENCED ANY ISSUES WITH THE MONOJECT SYRINGES PACKAGED AS COVIDIEN MONOJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102791 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THEY HAD A FAILURE OF THE CARDINAL MONOJECT SYRINGE - ITEM # 460SE - IN A SYRINGE PUMP. HOWEVER, THE COVIDIEN SYRINGE WITH THE SAME ITEM # 460SE WORKS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102789 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  CUSTOMER REPORTS: THE MEDELA PUMPS ARE REJECTING THE NEW 60ML ENFIT SYRINGES. WE DID MANAGE TO PULL ONE THAT FAILED WHEN PLACED IN THE PUMP. THE ONLY NOTICEABLE DIFFERENCE IS ONE IS MADE IN USA AND THE OTHER MADE IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102595 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THEY HAVE IDENTIFIED THAT THE CARDINAL HEALTH MONOJECT 60ML ENTERAL SYRINGES (REF (B)(4); LOT 230501) ARE NOT IDENTIFIED AS MONOJECT SYRINGES IN THEIR FEEDING PUMPS AND THEREFORE CANNOT DELIVER FEEDS TO BABIES. THIS IS CURRENTLY THE ONLY LOT NUMBER AVAILABLE TO THEM TO TEST, BUT 100% OF THOSE TESTED HAVE FAILED USING MULTIPLE PUMPS AND PUMP SETTINGS. THEY HAVE NOT EXPERIENCED ANY ISSUES WITH THE MONOJECT SYRINGES PACKAGED AS COVIDIEN MONOJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102591 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190502. One submission often covers many models, so check the product and lot details in each record.

• Z-0848-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
• Z-0847-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
• Z-0849-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE