Home / Recalls / Salter Labs / Z-2781-2015

Z-2781-2015 Class II Terminated

Recalled by Salter Labs — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
September 23, 2015
Initiation Date
August 4, 2015
Termination Date
May 6, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,975

Product Description

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.

Reason for Recall

The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

Distribution Pattern

Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.

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).

Other recalls by Salter Labs

  • Z-0796-2016 Class II — T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patien (January 5, 2016)
  • Z-2093-2014 Class II — Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration (June 25, 2014)
  • Z-0360-2014 Class II — Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; (November 1, 2013)
  • Z-1898-2012 Class II — Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, (May 30, 2012)