Z-0150-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 457,200 units
Product Description
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Reason for Recall
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Distribution Pattern
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.
Code Information
Product Code: 1186000777T; UDI/DI: 10192253025835 - each, 20192253025832 - box, 50192253025833 - case; Lot Numbers: 221101, 230601