FDAClass IIOctober 25, 2023

Monoject(TM) recall

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

Why was Monoject(TM) recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.

Product
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Recalling firm
Cardinal Health 200, LLC
Quantity
3.927,994 units
Distribution
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
Recall date
October 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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