Device product
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Z-0112-2024
Product summary
- Event
- Event 93019
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3.927,994 units
- Official record key
device-enforcement:Z-0112-2024
Official wording
Reason: Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
Code information: Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.
Distribution pattern: 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
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).