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