Z-0112-2024 Class II Ongoing
FDA device recall Z-0112-2024 was initiated by Cardinal Health 200, LLC on September 13, 2023 and is designated Class II. Reason for recall: Syringe contains conical tip that is not compatible with certain needleless IV connector(s). The recall status is ongoing. Affected quantity: 3.927,994 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- September 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3.927,994 units
Product Description
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Reason for Recall
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
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
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.