FDA Enforcement
Class I
Ongoing
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Recall: Z-0146-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0146-2024
- 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" 6 mL Syringe Luer-Lock Tip Soft Pack
Reason
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Code Info
Product Code: 1180600777; UDI/DI: 10192253034608 - each, 20192253034605 - box, 50192253034606 - case; Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206, 230207
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
3,936,682 units