Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
This recall is currently active, issued October 26, 2023. It was issued by Cardinal Health 200, Llc.
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- September 20, 2023
- Posted
- October 26, 2023
- Recall Number
- Z-0149-2024
- Quantity
- 1,097,048 units
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Distribution
US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
Lot / Code Info
Product Code: 1183500777; UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case; Lot Numbers: 221201, 230201, 230601, 230602
Root Cause
Vendor change control
Action Taken
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.