Cardinal Health 1mL (REF 8881101015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 26971564466817), received between Jun 4, 2024 and Jun 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ANONYMOUSLY VIA MEDWATCH THAT THE CUSTOMER'S FACILITY USES THE MONOJECT ORAL SYRINGES, 1 ML SIZE, FOR ORAL MEDICATIONS NEEDED IN THEIR NICU PATIENTS. STAFF NOTICED THAT THE NEWER VERSION OF THE MONOJECT ORAL SYRINGES FROM CARDINAL HEALTH HAVE A VERY LOOSE PLUNGER. THIS LACK OF RESISTANCE OF THE PLUNGER IN THE BARREL OF THE SYRINGE ALLOWS FOR MEDICATION TO BE EXPELLED OUT OF THE SYRINGE DESPITE BEING CAPPED. THE OLDER/ ORIGINAL VERSION OF THE ORAL MONOJECT 1 ML SYRINGES HAD MORE RESISTANCE WITH THE PLUNGER IN THE BARREL AND DID NOT HAVE THE ISSUE OF THE MEDICATION BEING EXPELLED. THE PRODUCT NUMBER FOR THESE MONOJECT ORAL SYRINGES DID NOT CHANGE WHEN THEY WERE CONVERTED TO THE CARDINAL HEALTH VERSION - PRODUCT NUMBER 8881101015. NO HARM TO ANY PATIENTS BUT PHARMACY STAFF DID HAVE TO RE-DRAW MULTIPLE DOSES FOR PATIENTS DUE TO EXPELLED MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465084 ↗

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-0849-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
• Z-0848-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
• Z-0850-2024 · Dec 28, 2023 · Open, Classified
  Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
• 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