Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

• Product Names: Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Pack (extended conical tip)
• Product Code: 1188100777
• Unique Device Identifier (UDI):
  • (01)10192253034783 (EA)
  • (01)20192253034780 (BX)
  • (01)50192253034781 (CS)
• Lot Numbers:
  • 221201
  • 230201
  • 230202

What to Do

• Do 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 affected product code and lots.
• Communicate with all personnel who use Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack 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.

Return the acknowledgment form included with the letter by fax: 614-652-9648 or email: GMB-FieldCorrectiveAction@cardinalhealth.com, whether there is affected product or not.

Reason for Recall

Cardinal Health is recalling certain lots of Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack due to an 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 may not receive the full dose of insulin because not all the medication will leave the syringe.

The use of affected product may cause serious adverse health consequences, including high (hyperglycemia) or low (hypoglycemia) blood sugar, fat breaking down too fast in the body (diabetic ketoacidosis) and death.

There have been no reported injuries and no reports of death.

Device Use

The Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack is used to administer insulin under the skin (subcutaneous) or through the blood vessels (intravenous) using a luer-compatible syringe for treatment of excess potassium in the blood (acute hyperkalemia).

Contact Information

Customers in the U.S. 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.

Additional FDA Resources

• FDA's Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.