FDA recall Z-0850-2024

Cardinal Health 200, LLC · Class I · device

Product

Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE

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.

Distribution

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

Key facts

Status
Ongoing
Initiation date
2023-12-28
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0850-2024