FDA recall Z-2037-2019

Cardinal Health 200, LLC · Class II · device

Product

Monoject Standard Hypodermic Needle Item code: 8881200029

Reason for recall

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Distribution

Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL

Key facts

Status
Completed
Initiation date
2019-04-30
Report date
2019-07-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2037-2019