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Monoject recallZ-0853-2024 · Cardinal Health 200, LLC · initiated Dec 28, 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

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

FDA root cause category: Process change control

What the company is doing

Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/28/2023 via FedEx. The notice explained the problem with the device, risk to patient, and requested the following actions be taken: 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 Enteral Syringes with ENFit (6, 12, 35, 60 mL) that they should not be used with enteral syringe feeding pumps. 3. POST a copy of this notification in your storeroom and clinical areas 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 [email protected], whether you have affected product or not. CONTACT the appropriate Customer Service group with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Distributor 800-635-6021 " All Other Customers 888-444-5440 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. A subsequent recall letter dated 2/2/2024 flagged URGENT MEDICAL DEVICE PRODUCT RECALL was issued informing the customer that the recall now involves all sizes of the Cardinal Health brand Monoject sterile Syringe Luer-Lock Soft Packs and Monoject sterile Enteral Syringes with the ENFit connection. This letter supersedes the previous communications. The letter explains the issue, risk to health, and lists the actions that are required. The actions were: 1. REVIEW your inventory for the

Recall details

Recall number
Z-0853-2024
Status
Open, Classified
Initiated by the company
Dec 28, 2023
Posted by the FDA
Feb 2, 2024
Recalling firm
Cardinal Health 200, LLC
Product code
FMF
Distribution
Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

Product description

Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777

Code information (models, lots, serial numbers)

UDI/DI 50192253034606 (Case), 20192253034605 (Box), 10192253034608 (Each), Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206, 230207

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 93676).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page