Z-0112-2024Class II

Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/

Name: Z-0112-2024 Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/
Creator: Cardinal Health 200, LLC
Published: 2023-09-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-09-13 / Open, Classified

FDA source

Cardinal Health 200, LLC began a recall of Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777 on 2023-09-13. FDA classified it as Class II and gives the reason as "Syringe contains conical tip that is not compatible with certain needleless IV connector(s)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0112-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-13
Posted: 2023-10-13
Recalling firm: Medtronic, Inc.
Product: Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Product code: FMF Syringe, Piston
Reason for recall: Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
FDA root cause: Process change control
Action: Cardinal Health notified consignees on about 09/13/2023 via letter titled "URGENT MEDICAL DEVICE PRODUCT CORRECTION." Customers were instructed to review inventory for the affected product code and lot, ensure all personnel are informed cease utilizing the affected product with needleless IV connectors, post a copy of the notification in the storeroom where the product is stored, and notify any customers if the product has been further distributed/forwarded. Additionally, customers were asked to complete and return the included acknowledgment form.
Quantity in commerce: 3.927,994 units
Distribution: 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: Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-13

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)