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Recall Observatory FDA recall evidence

Device product

Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

Z-0112-2024

September 13, 2023

Class II

Product summary

Firm
Cardinal Health 200, LLC
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

    reason.no_named_rule · v1.0.0

    Syringe contains conical tip that is not compatible with certain needleless IV connector(s).