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U.S. Department of Health and Human Services

Class 2 Device Recall Sunset Compressor Nebulizer

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  Class 2 Device Recall Sunset Compressor Nebulizer see related information
Date Initiated by Firm August 29, 2018
Create Date March 26, 2019
Recall Status1 Terminated 3 on June 12, 2020
Recall Number Z-1058-2019
Recall Event ID 81725
510(K)Number K091272  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
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.
Code Information Lot number 180223
Recalling Firm/
Manufacturer		 SANRAI INTERNATIONAL LLC
1701 North St Ste 40
Endicott NY 13760-5587
For Additional Information Contact Amarpreet Rai
607-429-8070
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAF and Original Applicant = BESMED HEALTH BUSINESS CORP.
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