FDA recall Z-0424-2021

Product

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

Reason for recall

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

Distribution

Distribution US Nationwide, Australia and Canada

Key facts

Status

Terminated

Initiation date

2020-09-25

Report date

2020-11-11

Termination date

2023-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

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