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
Product summary
- 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
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