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vPEP
D R BURTON HEALTHCARE, LLC · Model 1 · UDI-DI 00851232007127
BWF
Prescription
1
510(k) clearances
192
Adverse events (4 deaths)
1
Recalls
51
Facilities
Description
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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Get your free API keyRead the docsData 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.