General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKes...

FDA Device Recall #Z-3154-2024 — Class II — August 6, 2024

Recall Summary

Recall Number Z-3154-2024
Classification Class II — Moderate risk
Date Initiated August 6, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cypress Medical Products LLC
Location Richmond, VA
Product Type Devices
Quantity 3 Boxes (25 per box, 75 total units)

Product Description

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

Reason for Recall

The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.

Distribution Pattern

US Nationwide distribution in the states of CA, NV, NY.

Lot / Code Information

UDI-DI: 20612479170302;

Other Recalls from Cypress Medical Products LLC

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Z-3185-2024 Class II Acceava Respiratory Strep A, CLIA Waived, Catal... Aug 20, 2024
Z-2940-2024 Class II McKesson Syringe 60CC, Luer Lock Tip, Sterile, ... Jul 24, 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.