Z-2039-2024Class II

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS...

Name: Z-2039-2024 Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS...
Creator: Mckesson Medical-Surgical Inc. Corporate Office
Published: 2024-04-23
License: https://open.fda.gov/license/

Mckesson Medical-Surgical Inc. Corporate Office / initiated 2024-04-23 / Completed

FDA source

Mckesson Medical-Surgical Inc. Corporate Office began a recall of Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number... on 2024-04-23. FDA classified it as Class II and gives the reason as "Quarantined product was inadvertently distributed". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2039-2024
Classification: Class II
Status: Completed
Initiated: 2024-04-23
Posted: 2024-06-07
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Product: Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125
Product code: FMF Syringe, Piston
Reason for recall: Quarantined product was inadvertently distributed
FDA root cause: Component change control
Action: McKesson notified one consignee by telephone on 4/11/24. Spoke with Nurse and confirmed product was received and confirmed that four (4) boxes were picked up by a McKesson Driver and one (1) box was used.
Quantity in commerce: 5 Boxes (20 per box, 100 eaches)
Distribution: US Nationwide distribution in the state of NJ.
Product codes and lots: UDI-DI: 20884521012230 Lot Code: 330737X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2039-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2039-2024	Class II	Completed	Voluntary: Firm initiated	2024-06-19	2024-06-07

Product code FMF

K131641Class IIMonoject 60Ml Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)Nipro Medical Corporation / cleared 2013-08-28

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)