DeVilbiss Model 7305P-D Powered Suction Unit

FDA Device Recall #Z-2246-2016 — Class II — May 23, 2016

Recall Summary

Recall Number Z-2246-2016
Classification Class II — Moderate risk
Date Initiated May 23, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DeVilbiss Healthcare LLC
Location Somerset, PA
Product Type Devices
Quantity 48 units

Product Description

DeVilbiss Model 7305P-D Powered Suction Unit

Reason for Recall

A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

Distribution Pattern

US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC

Lot / Code Information

Serial numbers: PD465146 - PD465193

Other Recalls from DeVilbiss Healthcare LLC

Recall # Classification Product Date
Z-1558-2023 Class II DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENT... Mar 9, 2023
Z-0724-2023 Class II DeVilbiss, 525 5-liter Oxygen Concentrator Mod... Nov 18, 2022
Z-0229-2023 Class II 125 series iGO2 Portable Oxygen Concentrator-in... Sep 19, 2022
Z-1949-2014 Class III DeVilbiss Model DV5x Series CPAP units. For use... May 13, 2014
Z-2319-2013 Class II DeVilbiss Vacu-Aide QSU Suction Unit (Disposabl... Mar 7, 2013

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.