NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate...
FDA Device Recall #Z-2781-2015 — Class II — August 4, 2015
Recall Summary
| Recall Number | Z-2781-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 4, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Salter Labs |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 8,975 |
Product Description
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
Reason for Recall
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
Distribution Pattern
Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.
Lot / Code Information
Lot Numbers 042015 through 070615A Series 8660, 8960, 8961, 8966, 8984. Nebulizers (part numbers 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7), Inspiratory valve cap (part number 600116).
Other Recalls from Salter Labs
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0796-2016 | Class II | T-piece Nebulizer with in-line connectors, Part... | Jan 5, 2016 |
| Z-2093-2014 | Class II | Oxygen Mask, Model No. 8120-7 Product Usage:... | Jun 25, 2014 |
| Z-0360-2014 | Class II | Salter Labs EtCO2 Sample line 15' (4.6 M) tube,... | Nov 1, 2013 |
| Z-1898-2012 | Class II | Adult Divided Cannula end tidal C)2 sampling w/... | May 30, 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.