McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, ...
FDA Device Recall #Z-2940-2024 — Class II — July 24, 2024
Recall Summary
| Recall Number | Z-2940-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 24, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cypress Medical Products LLC |
| Location | Richmond, VA |
| Product Type | Devices |
| Quantity | 24,693,200 eaches (US) |
Product Description
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Reason for Recall
Affected syringes lack FDA clearance.
Distribution Pattern
US distribution only. Domestic distribution nationwide.
Lot / Code Information
All lots of the affected product 102-S60C, SYRINGE, LL 60CC which are within their expiration date, are being recalled. Products were manufactured within the last five years. Affected lots: All lots beginning with alpha characters CLN. UDI-DI (01)30612479170316
Other Recalls from Cypress Medical Products LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3184-2024 | Class II | BinaxNOW Respiratory Strep A Test Kit, CLIA Wai... | Aug 20, 2024 |
| Z-3185-2024 | Class II | Acceava Respiratory Strep A, CLIA Waived, Catal... | Aug 20, 2024 |
| Z-3154-2024 | Class II | General Purpose Syringe McKesson 60 mL Luer Loc... | Aug 6, 2024 |
| Z-2473-2021 | Class II | McKesson Lap Sponge, X-Ray Detectable 12"x 12"... | Aug 11, 2021 |
| Z-1080-2019 | Class III | McKesson Consult Diagnostic Immunochemical Feca... | Feb 27, 2019 |
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.