Z-0147-2024Class I

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Name: Z-0147-2024 Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Creator: Cardinal Health 200, LLC
Published: 2023-09-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-09-20 / Open, Classified / root cause: supplier

FDA source

Cardinal Health 200, LLC began a recall of Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack on 2023-09-20. FDA classified it as Class I and gives the reason as "Demonstrated recognition and compatibility issues with syringe infusion pumps". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0147-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-20
Posted: 2023-10-26
Recalling firm: Medtronic, Inc.
Product: Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Product code: FMF Syringe, Piston
Reason for recall: Demonstrated recognition and compatibility issues with syringe infusion pumps.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: 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.
Quantity in commerce: 3,084,300 units
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 codes and lots: Product Code: 1181200777T; UDI/DI: 10192253025811 - each, 20192253025818 - box, 50192253025819 - case; Lot Numbers: 221101, 221102, 221103, 221104

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0147-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0145-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0146-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0147-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0148-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0149-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26
Z-0150-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-26

Product code FMF

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)