Cardinal Health 12mlRecalls & 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- 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-0848-2024 · Root cause: Process change control · Recall details · FDA record ↗
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-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-0849-2024 · Dec 28, 2023 · Open, ClassifiedCardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
- Z-0850-2024 · Dec 28, 2023 · Open, ClassifiedCardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Other Enteral Syringes With Enteral Specific Connectors devices
- Cardinal Health 1mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall5 reports
- 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 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
- 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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