Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-0310-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 25, 2024

Date Posted: November 20, 2024

Recall Number: Z-0310-2025

Event ID: 95487

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.

Status: Ongoing

Product Quantity: 371,326 units

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated