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BUBBLE HUMIDIFIER 400cc

BESMED HEALTH BUSINESS CORP. · Model HB-72600 · UDI-DI 04716770726007

KFZ Prescription
10
510(k) clearances
801
Adverse events (2 deaths)
3
Recalls
120
Facilities

Description

BUBBLE HUMIDIFIER 400cc

Recalls

DateFirmReason
2021-03-16Cardinal 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.
2015-11-20Bigwall Enterprises"The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investi
2003-04-15KAZ Inc.Humidifiers may overheat.

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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.