OxyMask O2 Adult REF OM-1125-14
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model: OM-1125-14 Lot Number: W73887
- 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:
- Southmedic, Inc.
- Reason for Recall:
- Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
OxyMask O2 Adult REF OM-1125-14
Product Codes/Lot Numbers:
Model: OM-1125-14 Lot Number: W73887
Distribution:
Distributed in: IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2141-2021
Related Recalls
Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
Scalpels lot contains non-sterile products labeled as sterile.
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.