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U.S. Department of Health and Human Services

Class 2 Device Recall NebuTech Nebulizer

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  Class 2 Device Recall NebuTech Nebulizer see related information
Date Initiated by Firm August 04, 2015
Date Posted September 17, 2015
Recall Status1 Terminated 3 on May 06, 2016
Recall Number Z-2781-2015
Recall Event ID 71909
510(K)Number K962879  K961476  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
Code Information Lot Numbers 042015 through 070615A Series 8660, 8960, 8961, 8966, 8984. Nebulizers (part numbers 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7), Inspiratory valve cap (part number 600116).
Recalling Firm/
Manufacturer		 Salter Labs
2365 Camino Vida Roble
Carlsbad CA 92011-1505
For Additional Information Contact Salter Labs Customer Support
800-421-0024
Manufacturer Reason
for Recall		 The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
FDA Determined
Cause 2		 Component change control
Action Salter Labs sent a Medical Device Recall letter dated July 24 2015. The letter identified the affected product, problem and actions to be taken. The letter states that all affected product can be returned to Salter Labs for replacement at no charge with product specifically inspected for a tighter fit on the inspiratory valve cap. Customers were instructed to complete and return the Return Response Form as soon as possible. For any questions contact Salter Labs Customer Support at 800-421-0024 or the local Salter Labs representative.
Quantity in Commerce 8,975
Distribution Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.
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 = SALTER LABS
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