Home / Recalls / Salter Labs / Z-2093-2014

Z-2093-2014 Class II Terminated

Recalled by Salter Labs — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
July 30, 2014
Initiation Date
June 25, 2014
Termination Date
September 10, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
584 units

Product Description

Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

Reason for Recall

The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

Distribution Pattern

Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.

Code Information

Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614

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-2781-2015 Class II — NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer (August 4, 2015)
  • 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)