Device product
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Z-0149-2024
Product summary
- Event
- Event 93075
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,097,048 units
- Official record key
device-enforcement:Z-0149-2024
Official wording
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Code information: Product Code: 1183500777; UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case; Lot Numbers: 221201, 230201, 230601, 230602
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.
Derived failure modes
-
Unknown
Demonstrated recognition and compatibility issues with syringe infusion pumps.