Cardinal Health 200, LLC Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Brand
Cardinal Health 200, LLC
Lot Codes / Batch Numbers
Product Code: 1183500777, UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case, Lot Numbers: 221201, 230201, 230601, 230602
Products Sold
Product Code: 1183500777; UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case; Lot Numbers: 221201, 230201, 230601, 230602
Cardinal Health 200, LLC is recalling Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack due to Demonstrated recognition and compatibility issues with syringe infusion pumps.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Recommended Action
Per FDA guidance
Cardinal Health notified customers on about 09/20/2023 via "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter sent FedEx next day delivery. Customers were instructed to: 1. REVIEW your inventory for the affected product codes and lots. Location of product code and lot are shown in above listed table and below example labeling. 2. COMMUNICATE with all personnel that utilize the Cardinal Health Monoject" Luer-Lock Tip syringes (1, 6, 12, 20, 35 and 60 mL) that they should not be used with syringe infusion pumps. 3. POST a copy of this notification in your storeroom where the product is stored. 4. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this medical device product correction and share a copy of this notice. 5. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. complete and return the provided acknowledgement form. For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026