SANRAI INTERNATIONAL LLC: Medical Device Recall in 2019 - (Recall #: Z-1058-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 29, 2018

Date Posted: April 3, 2019

Recall Number: Z-1058-2019

Event ID: 81725

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.

Status: Terminated

Product Quantity: 150 units

Code Information:

Lot number 180223

Distribution Pattern:

International distribution in the country of South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated