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Class 2 Device Recall NebuTech Nebulizer |
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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
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Product Classification |
Nebulizer (direct patient interface) - Product Code CAF
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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
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For Additional Information Contact |
Salter Labs Customer Support 800-421-0024
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Manufacturer Reason for Recall |
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
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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
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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.
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510(K) Database |
510(K)s with Product Code = CAF and Original Applicant = SALTER LABS
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