Z-0424-2021 Class II Terminated
FDA device recall Z-0424-2021 was initiated by Cardinal Health 200, LLC on September 25, 2020 and is designated Class II. 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 th… The recall status is terminated (terminated October 30, 2023). Affected quantity: 519,676 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- September 25, 2020
- Termination Date
- October 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 519,676 units
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
Distribution Pattern
Distribution US Nationwide, Australia and Canada
Code Information
Lot Number: 011144 Expanded Recall 11/4/20: Lot Number: 011145