Cardinal Health 35mlRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 06971564466240), received between Apr 12, 2024 and Apr 14, 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-0849-2024 · 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 14, 2024Compatibility Problem; Compatibility Problem

  THE SYRINGE CAN'T BE USED WITH THE FEEDING PUMPS, THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102960 ↗
• MalfunctionApr 13, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT IN THE AM THEY IDENTIFIED A MAJOR PROBLEM WITH THE CARDINAL ENFIT 35 ML SYRING, IT WILL NOT WORK IN THEIR MEDELA FEEDING PUMP. THEY HAVE THE PUMP PROGRAMMED FOR THE ENFIT BRAND AND BIOMED HAS BEEN TO THE UNIT TO EVALUATE AND ARE UNABLE TO CHANGE THE PUMP SETTINGS. THEY DO NOT HAVE ANY OTHER FEEDING PUMPS AVAILABLE TO THE NICU. WHAT WAS IDENTIFIED IS THAT THE NICU HAS BEEN USING THE ENFIT SYRINGES (PURPLE ONES) PER THE CHANGE HOWEVER THEY HAVE BEEN RECEIVING THE COVIDIEN BRAND NOT THE CARDINAL BRAND. TODAY THEY RECEIVED THE CARDINAL BRAND AND THEY DO NOT WORK. THEY LOOK SIMILAR BUT ARE A DIFFERENT DIAMETER. THEY DO NOT WORK IN THE PUMPS. THE WORK AROUND FOR TODAY IS TO USE THE COVIDIEN 60ML SYRINGES. HOWEVER THEY HAVE CONCERNS THAT THEY MAY ALSO BE SWITCHED TO THE CARDINAL BRAND LEAVING NO WORK AROUND TO FEED THE NICU INFANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102792 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  AS ALWAYS BEEN THIS CODE WHETHER THE PACKAGING SAID COVIDIEN OR CARDINAL. ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON 31OCT2023 STATED THAT SHE MANAGES THE SOFTWARE FOR THE PUMPS IN THE NICU (IN WHICH THE SYRINGES IN QUESTION ARE INCOMPATIBLE WITH). THEY USE THE MEDFUSION 4000 PUMPS (VERSION V1.6.1) MANAGED BY ICU MEDICAL (FORMERLY SMITHS MEDICAL). SHE REACHED OUT TO THE PUMP VENDOR TO INQUIRE ABOUT MORE INFORMATION. THE REP SHE SPOKE WITH INDICATED THAT THIS ENFIT SYRINGE ISSUE IS RELATED TO A SIMILAR PROBLEM WITH LUER-LOCK SYRINGES REPORTED OVER THE LAST COUPLE OF MONTHS. CURRENTLY, THEY STILL HAVE SUPPLY IN THE NICU OF THE MONOJECT ENFIT SYRINGES (REF (B)(4)), BUT IT'S THE OLD COVIDIEN PACKAGING, LOT 322648X. THE INCOMPATIBLE LOT NUMBER IS 230501 WITH THE CARDINAL HEALTH MONOJECT PACKAGING. THEY ARE ASKING WHETHER THAT ABOVE LOT NUMBER (230501) IS UNIQUE AND THE ONLY INCOMPATIBILITY ISSUE THEY WILL ENCOUNTER, OR HAVE THERE BEEN ISSUES REPORTED WITH THE CARDINAL HEALTH BRANDED MONOJECT ENFIT SYRINGES (SIMILAR TO THE LUER-LOCK SYRINGE ISSUES)? THEY HAVE SOME OTHER OPTIONS TO MANAGE THIS ISSUE WITH THE PUMPS, BUT WAS WONDERING IF THERE WAS ANY FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095875 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THE SYRINGES CANNOT BE USED WITH THE FEEDING PUMPS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095858 ↗

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-0850-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
• 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