Z-1058-2019Class II

Sunset Compressor Nebulizer, Model NEB100 -

Name: Z-1058-2019 Sunset Compressor Nebulizer, Model NEB100 -
Creator: Sanrai International Llc
Published: 2018-08-29
License: https://open.fda.gov/license/

Sanrai International LLC / initiated 2018-08-29 / Terminated / root cause: design

FDA source

SANRAI INTERNATIONAL LLC began a recall of Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide... on 2018-08-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1058-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-29
Posted: 2019-03-26
Terminated: 2020-06-12
Recalling firm: Sanrai International LLC
Product: 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.
Product code: CAF Nebulizer (Direct Patient Interface)
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.
Root cause tag: design
FDA root cause: Device Design
Action: Notification letters were distributed to customers on 8/29/18.
Quantity in commerce: 150 units
Distribution: International distribution in the country of South Africa.
Product codes and lots: Lot number 180223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1058-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1058-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-26

Product code CAF

K091272Class IIBesmed Jet Nebulizer Bottle SetBesmed Health Business Corp / cleared 2009-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)