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vPEP

D R BURTON HEALTHCARE, LLC · Model 1 · UDI-DI 10851232007018

BWF Prescription

510(k) clearances

180

Adverse events (4 deaths)

Recalls

Facilities

Description

This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.

Recalls

Date	Firm	Reason
2020-12-21	Smiths Medical ASD Inc.	Shipping box may contain wrong model.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.