FDA-Device2020-11-11Class II

Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248

Cardinal Health 200, LLC
Hazard

Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle

Sold states
Distribution US Nationwide, Australia and Canada
Affected count
519,676 units
Manufactured in
15 Hampshire St Bldg 5, N/A, Mansfield, MA, United States
Products
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0424-2021

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