FDA-Device2024-02-14Class I
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Cardinal Health 200, LLC
Hazard
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.
Sold states
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Affected count
397676 units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0850-2024Don't want to check this manually?
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