PlainRecalls
FDA Devices Critical Class I Ongoing

Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

Reported: November 20, 2024 Initiated: September 25, 2024 #Z-0310-2025

Product Description

Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

Reason for Recall

Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
371,326 units
Distribution
Nationwide
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777. Recalled by Cardinal Health 200, LLC. Units affected: 371,326 units.
Why was this product recalled?
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 20, 2024. Severity: Critical. Recall number: Z-0310-2025.