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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Salter Labs
- Reason for Recall:
- The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2093-2014
Related Recalls
Reports that the T-piece does not fit on the nebulizer.
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.