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Recall Observatory FDA recall evidence

Device product

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

Z-0150-2024

September 20, 2023

Class I

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 93075
Status
Ongoing
Classification
Class I
Quantity
457,200 units
Official record key
device-enforcement:Z-0150-2024

Official wording

Reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.

Code information: Product Code: 1186000777T; UDI/DI: 10192253025835 - each, 20192253025832 - box, 50192253025833 - case; Lot Numbers: 221101, 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

    reason.no_named_rule · v1.0.0

    Demonstrated recognition and compatibility issues with syringe infusion pumps.