FDA Enforcement
Class I
Ongoing
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Recall: Z-0148-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0148-2024
- Event ID
- 93075
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- September 20, 2023
- Classification Date
- October 26, 2023
- Address
- 3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States
Description
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Reason
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Code Info
Product Code: 1182000777; UDI/DI: 10192253034677 - each, 20192253034674 - box, 50192253034675 - case; Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206
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.
Quantity
4,913,520 units