Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2093-2014

June 25, 2014

Class II

Product summary

Firm
Salter Labs
Event
Event 68701
Status
Terminated
Classification
Class II
Quantity
584 units
Official record key
device-enforcement:Z-2093-2014

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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