Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to faci...
FDA Device Recall #Z-0424-2021 — Class II — September 25, 2020
Recall Summary
| Recall Number | Z-0424-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 25, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health 200, LLC |
| Location | Mansfield, MA |
| Product Type | Devices |
| 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
Lot / Code Information
Lot Number: 011144 Expanded Recall 11/4/20: Lot Number: 011145
Other Recalls from Cardinal Health 200, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1203-2026 | Class II | Chest Drainage Units and Accessories: Produc... | Dec 26, 2025 |
| Z-0897-2026 | Class II | ChemoPlus gowns: Product Code Product Descript... | Nov 12, 2025 |
| Z-0207-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0208-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0211-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.