Syringe Recall Alert: Cardinal Health Withdraws Specific Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs Over Compatibility Issues with Needleless Connectors
This recall pertains to the removal of specific devices from the market or usage locations. The FDA has categorized this recall as the highest level of seriousness. Continued use of this device could result in severe injury or potentially fatal outcomes.
Product Information
- Product Names: Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Pack (extended conical tip)
- Product Code: 1199100777
- Unique Device Identifier (UDI):
- (01)10192253034783 (EA)
- (01)20192253034780 (BX)
- (01)50192253034781 (CS)
- Lot Numbers:
- 221201
- 230201
- 230202
Recommended Actions
- Avoid using syringes from the impacted product codes and lot numbers for intravenous (IV) push insulin via a needleless connector.
On September 25, 2024, Cardinal Health dispatched an Urgent Medical Device Recall letter to all customers impacted, advising the following steps:
- Examine your inventory for the affected product codes and lot numbers.
- Inform all users of the Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack that it should not be employed for IV push insulin with needleless connectors.
- Display a copy of this notification in the storage area of the product.
- Alert anyone who may have received or will be receiving this product about this recall notice.
Please return the acknowledgment form enclosed with the letter via fax at 614-652-9648 or email it to GMB-FieldCorrectiveAction@cardinalhealth.com, regardless of whether you possess affected products.
Reason for the Recall
Cardinal Health is recalling specific lots of Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack due to their incompatibility with needleless IV connectors. Using these devices for IV push insulin may inhibit the full delivery of medication, posing risks of incomplete dosing.
The usage of these syringes can lead to severe health complications, including both elevated (hyperglycemia) and lowered (hypoglycemia) blood sugar levels, rapid fat breakdown in the body (diabetic ketoacidosis), or even fatalities.
No injuries or deaths have been reported as a result of this issue as of now.
Device Utilization
The Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack is utilized for administering insulin either under the skin (subcutaneous) or directly into blood vessels (intravenous), particularly for treating high potassium levels in the blood (acute hyperkalemia).
Contact Information
Those in the U.S. with inquiries regarding this recall can reach out to the appropriate Cardinal Health customer service line: Hospital – 1-800-964-5227, distributor – 1-800-635-6021, all others – 1-888-444-5440.
Further FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) is essential for recognizing individual medical devices available in the United States, from production to distribution and use by patients. The UDI system facilitates accurate reporting and assessment of adverse event occurrences to swiftly identify and rectify potential issues.
Reporting Issues
Health care professionals and consumers are encouraged to report adverse reactions or quality concerns via MedWatch: the FDA Safety Information and Adverse Event Reporting Program.