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.
FDA Recall Z-2781-2015 · Posted 2015-09-17
Advertisement
Recalling FirmSalter Labs
Recall StatusTerminated
Product CodeCAF
Date Initiated2015-08-04
Date Terminated2016-05-06
Product Quantity8,975
Reason for Recall
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement