Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.
FDA Recall Z-1058-2019 · Posted None
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Recalling FirmSANRAI INTERNATIONAL LLC
Recall StatusTerminated
Product CodeCAF
Date Initiated2018-08-29
Date Terminated2020-06-12
Product Quantity150 units
Reason for Recall
The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
Firm Action
Notification letters were distributed to customers on 8/29/18.
Root Cause
Device Design
Distribution Pattern
International distribution in the country of South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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