Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-0424-2021

September 25, 2020

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 86554
Status
Terminated
Classification
Class II
Quantity
519,676 units
Official record key
device-enforcement:Z-0424-2021

Official wording

Reason: 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

Code information: Lot Number: 011144 Expanded Recall 11/4/20: Lot Number: 011145

Distribution pattern: Distribution US Nationwide, Australia and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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