Monoject recallZ-0112-2024 · Cardinal Health 200, LLC · initiated Sep 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
FDA root cause category: Process change control
What the company is doing
Cardinal Health notified consignees on about 09/13/2023 via letter titled "URGENT MEDICAL DEVICE PRODUCT CORRECTION." Customers were instructed to review inventory for the affected product code and lot, ensure all personnel are informed cease utilizing the affected product with needleless IV connectors, post a copy of the notification in the storeroom where the product is stored, and notify any customers if the product has been further distributed/forwarded. Additionally, customers were asked to complete and return the included acknowledgment form.
Recall details
- Recall number
- Z-0112-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 13, 2023
- Posted by the FDA
- Oct 13, 2023
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 3.927,994 units
- Product code
- FMF
- 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
Product description
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Code information (models, lots, serial numbers)
Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Monoject 1180100777Cardinal Health 200, LLC · Syringe, piston3 recalls4 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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