FDA Enforcement
Class I
Ongoing
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
Recall: Z-0848-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0848-2024
- Event ID
- 93676
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 28, 2023
- Classification Date
- February 2, 2024
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States
Description
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
Reason
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.
Code Info
UDI/DI 26971564466237 (Case), 16971564466230 (Box), 06971564466233 (Each), Lot Numbers: 230501, 230502 and 230601
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
Quantity
60760 units