Recall Z-2093-2014— Salter Labs
Class II · Terminated
Class II FDA medical device recall by Salter Labs, initiated 2014-06-25, terminated 2014-09-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather..
- Recalling firm
- Salter Labs
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-25
- Terminated
- 2014-09-10
- Firm location
- Carlsbad, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.