Cardinal Health 1ml (REF 401SE)Recalls & reported problems
Jiangsu Caina Medical Co.,Ltd · The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups. · Class 2
All models of Cardinal Health (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 06971564466202), received between Apr 12, 2024 and Apr 12, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Dec 28, 2023Class IOpen, Classified
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Z-0858-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Compatibility Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 19096584 ↗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 19096580 ↗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 19096579 ↗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 19096291 ↗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 19096290 ↗
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, ClassifiedCardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
- Z-0847-2024 · Dec 28, 2023 · Open, ClassifiedCardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
- Z-0848-2024 · Dec 28, 2023 · Open, ClassifiedCardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
- Z-0849-2024 · Dec 28, 2023 · Open, ClassifiedCardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
Other Enteral Syringes With Enteral Specific Connectors devices
- Cardinal Health 35mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall4 reports
- Cardinal Health 60mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall4 reports
- Cardinal Health 6mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Cardinal Health 12mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Cardinal Health 3mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Medline NON66160Medline Industries, Inc. · Enteral Syringes with enteral specific connectors4 reports
- ENFit Syringe PNM-S60NCAvanos Medical, Inc. · Enteral Syringes with enteral specific connectors3 reports
- ENFit Syringe NM-S60NCAvanos Medical, Inc. · Enteral Syringes with enteral specific connectors1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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