FDA-Device2024-11-20Class I

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

Cardinal Health 200, LLC
Hazard

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.

Sold states
Nationwide
Affected count
371,326 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0310-2025

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