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Monoject recallZ-0148-2024 · Cardinal Health 200, LLC · initiated Sep 20, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Demonstrated recognition and compatibility issues with syringe infusion pumps.

FDA root cause category: Vendor change control

What the company is doing

Cardinal Health notified customers on about 09/20/2023 via "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter sent FedEx next day delivery. Customers were instructed to: 1. REVIEW your inventory for the affected product codes and lots. Location of product code and lot are shown in above listed table and below example labeling. 2. COMMUNICATE with all personnel that utilize the Cardinal Health Monoject" Luer-Lock Tip syringes (1, 6, 12, 20, 35 and 60 mL) that they should not be used with syringe infusion pumps. 3. POST a copy of this notification in your storeroom where the product is stored. 4. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this medical device product correction and share a copy of this notice. 5. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB [email protected], whether you have affected product or not. complete and return the provided acknowledgement form. For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.

Recall details

Recall number
Z-0148-2024
Status
Open, Classified
Initiated by the company
Sep 20, 2023
Posted by the FDA
Oct 26, 2023
Recalling firm
Cardinal Health 200, LLC
Quantity
4,913,520 units
Product code
FMF
Distribution
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.

Product description

Monoject 20 mL Syringe Luer-Lock Tip Soft Pack

Code information (models, lots, serial numbers)

Product Code: 1182000777; UDI/DI: 10192253034677 - each, 20192253034674 - box, 50192253034675 - case; Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93075).

Sources and updates

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