Cardinal Health is recalling certain lots of Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Packs due to incompatibility with needleless IV connectors. If the affected device is used to administer IV push insulin through a needleless connector, it may increase the risk that the patient will not receive the full dose of insulin because not all the medication will leave the syringe.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.
The affected product includes:
- Monoject U-100 1 mL Luer-Lock Insulin Syringe with extended conical tip
- Monoject U-100 1 mL Luer-Lock Insulin Syringe with flat plunger tip
- Product Code: 1199100777
- Unique Device Identifier (UDI):
- (01)10192253034783 (EA)
- (01)20192253034780 (BX)
- (01)50192253034781 (CS)
- Lot Numbers:
What to DoDo not use syringes from the affected product code and lot numbers to administer intravenous (IV) push insulin using a needleless connector.
On September 25, 2024, Cardinal Health sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Review inventory for the affected product code and lots.
- Communicate with all personnel who use Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Packs that it should not be used to administer IV push insulin using a needleless connector.
- Post a copy of this notification where the product is stored.
- Notify anyone who may have received or will receive this product about this notice.
Customers with questions about this recall should contact the appropriate Cardinal Health customer service group:
- Hospital: 1-800-964-5227
- Distributor: 1-800-635-6021
- All others: 1-888-444-5440