Medical device recalls High risk

Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

Recall date
September 25, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0310-2025
FDA classification
Class I
Brand / firm
Cardinal Health 200, LLC
Sold / distributed
Nationwide

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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