PlainRecalls
FDA Devices Critical Class I Ongoing

Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

Reported: February 14, 2024 Initiated: December 28, 2023 #Z-0858-2024

Product Description

Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

Reason for Recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Details

Recalling Firm
Cardinal Health 200, LLC
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, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE. Recalled by Cardinal Health 200, LLC.
Why was this product recalled?
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Critical. Recall number: Z-0858-2024.