Z-0310-2025Class I

Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

Name: Z-0310-2025 Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Creator: Cardinal Health 200, LLC
Published: 2024-09-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-09-25 / Open, Classified

FDA source

Cardinal Health 200, LLC began a recall of Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 on 2024-09-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0310-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-09-25
Posted: 2024-11-08
Recalling firm: Medtronic, Inc.
Product: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Product code: MEG Syringe, Antistick
Reason for recall: 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: Under Investigation by firm
Action: 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
Quantity in commerce: 371,326 units
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0310-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0310-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-08

Product code MEG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)