Device product
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Z-0145-2024
Product summary
- Event
- Event 93075
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3,113,846 units
- Official record key
device-enforcement:Z-0145-2024
Official wording
Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Code information: Product Code: 1180100777; UDI/DI: 10192253034530 - each, 20192253034537 - box, 50192253034538 - case; Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601
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.