FDA Warns – Product defect prompts Cardinal Health to remove 3 lots of Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs

According to the FDA, Cardinal Health has issued a recall of their Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs after determining that they do not fit correctly with needleless IV connectors. The company sent the recall letter on September 25, 2024.

The Cardinal Health recall applies to three lots of their Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Pack with the extending conical tip (Product Code 1188100777). The UDIs for the impacted devices are (01)10192253034783 (EA), (01)20192253034780 (BX), and (01)50192253034781 (CS). The lot numbers included in the recall are 221201, 230201, and 230202. Health care professionals use the Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack along with a luer-compatible syringe to deliver insulin subcutaneously or intravenously in patients with elevated plasma levels of potassium.

The company recalled the syringes after finding that they do not connect properly with needleless IV connectors. As a result, when using the recalled Monoject U-100 mL Insulin Syringes, health care providers will encounter problems ensuring that patients receive the full dose of insulin, as some of the medication remains in the syringe. While Cardinal Health has not received any reports of injury connected to the recalled product, continued use of the syringes does put patients at risk. If a patient fails to receive a full dose of insulin, they could develop “high (hyperglycemia) or low (hypoglycemia) blood sugar, fat breaking down too fast in the body (diabetic ketoacidosis) and death.”

Cardinal Health advises all health care providers and facilities to cease use of the recalled Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs to administer IV insulin with needleless connectors. The company asks that providers post notice of the recall wherever the syringes are stored. Furthermore, all customers are asked to complete the acknowledgement form included with the company’s Urgent Medical Device Recall letter and to return the form by email to GMB-FieldCorrectiveAction@cardinalhealth.com or by fax to 614-652-9648.

Anyone with questions or concerns about the recall can contact Cardinal Health’s customer service line at:

  • For hospitals: 1-800-964-5227
  • For distributors: 1-800-635-6021
  • All others : 1-888-444-5440

Patients and health care providers can report any new adverse health events related to use of Cardinal Health’s Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs through the FDA’s MedWatch Online Voluntary Reporting Form.

 

If you or a loved one has suffered an injury or adverse health outcome linked to use of Cardinal Health’s Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.