Recall Z-1058-2019— SANRAI INTERNATIONAL LLC

Name: FDA recall Z-1058-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-29

Class II · Terminated

Class II FDA medical device recall by SANRAI INTERNATIONAL LLC, initiated 2018-08-29, terminated 2020-06-12. It names one FDA 510(k) clearance: K091272. 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.. Reason: 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..

Recalling firm: SANRAI INTERNATIONAL LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-29
Terminated: 2020-06-12
Firm location: Endicott, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K091272 — BESMED JET NEBULIZER BOTTLE SETBesmed Health Business Corp·cleared 2009-11-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.