FDA Enforcement Class II Completed

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

Recall: Z-2039-2024 · Reported June 19, 2024

Enforcement

Recall Number
Z-2039-2024
Event ID
94595
Classification
Class II
Status
Completed
Product Type
Devices
Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Telephone
Report Date
June 19, 2024
Initiation Date
April 23, 2024
Classification Date
June 7, 2024
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States

Description

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

Reason

Quarantined product was inadvertently distributed

Code Info

UDI-DI: 20884521012230 Lot Code: 330737X

Distribution

US Nationwide distribution in the state of NJ.

Quantity

5 Boxes (20 per box, 100 eaches)