Monoject recallZ-0310-2025 · Cardinal Health 200, LLC · initiated Sep 25, 2024
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
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
FDA root cause category: Under Investigation by firm
What the company is doing
Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 09/25/2024 via overnight mail. The notice explained the issue, risk to health, and requested the following actions: 1. REVIEW inventory for the affected product code and lots. 2. COMMUNICATE with all personnel who utilize the Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack that it should not be used for administration of IV push insulin via needleless connector. 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 or to whom you plan to send the product 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 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440
Recall details
- Recall number
- Z-0310-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2024
- Posted by the FDA
- Nov 8, 2024
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 371,326 units
- Product code
- MEG
- Distribution
- Nationwide
Product description
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Code information (models, lots, serial numbers)
UDI/DI 10192253034783 (EA), Lot Number 221201, exp. 2027-11-30; UDI/DI 20192253034780 (BX), Lot Number 230201, exp. 2028-01-31; UDI/DI 50192253034781 (CS), Lot Number 230202,exp. 2028-02-01
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Monoject 1188100777Cardinal Health, Inc. · Syringe, piston1 recall9 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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