FDAFDA · Food and drugs·Recall number Z-0310-2025
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Published November 20, 2024 · Recall initiated: September 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Nationwide
- Lot
- UDI/DI 10192253034783 (EA), Lot Number 221201, exp. 2027-11-30; UDI/DI 20192253034780 (BX), Lot Number 230201, exp. 2028-01-31; UDI/DI 50192253034781 (CS), Lot Number 230202,exp. 2028-02-01
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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