FDAClass INovember 20, 2024

Monoject U-100 recall

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

Why was Monoject U-100 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Recalling firm
Cardinal Health 200, LLC
Quantity
371,326 units
Distribution
Nationwide
Recall date
November 20, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls