FDAFDA · Food and drugs·Recall number Z-2093-2014
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.
Published July 30, 2014 · Recall initiated: June 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Salter Labs
- Distributor
- Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
- Lot
- Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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