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Flexichamber

AVADEL PHARMACEUTICALS (USA), INC. · Model Anti-Static Valved Collapsible Holding Chamber · UDI-DI 00313551000000

NVP Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

DEMO UNIT

Recalls

Date	Firm	Reason
2021-03-16	Cardinal Health Inc.	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
2021-03-16	Cardinal Health Inc.	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
2016-05-16	FSC Laboratories, Inc	Product had torn/loose seal around the mouthpiece.

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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.