PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 11, 2020 Initiated: September 25, 2020 #Z-0424-2021

Product Description

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

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
519,676 units
Distribution
Distribution US Nationwide, Australia and Canada
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Cardinal Health 200, LLC. Units affected: 519,676 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0424-2021.