Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Co...

FDA Device Recall #Z-2165-2013 — Class II — August 22, 2013

Recall Summary

Recall Number Z-2165-2013
Classification Class II — Moderate risk
Date Initiated August 22, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxa Corporation
Location Englewood, CO
Product Type Devices
Quantity 34 cases

Product Description

Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.

Reason for Recall

Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.

Distribution Pattern

Distributed to One Customer in NC.

Lot / Code Information

Lot or Serial No. 785518

Other Recalls from Baxa Corporation

Recall # Classification Product Date
Z-1752-2013 Class II ExactaMix 1200 and 2400 Compounders. Used as... Jun 4, 2013
Z-0156-2013 Class II Repeater Pump, Class II device used for facilit... Oct 3, 2012

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.