PlainRecalls
FDA Devices Critical Class I Ongoing

Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

Reported: February 14, 2024 Initiated: December 28, 2023 #Z-0847-2024

Product Description

Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

Reason for Recall

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.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
20186 units
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE. Recalled by Cardinal Health 200, LLC. Units affected: 20186 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Critical. Recall number: Z-0847-2024.