Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)
- 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 loose or missing CO2 diffusers which could result in a non-functioning mask.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Product Codes/Lot Numbers:
Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1288-2018
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.
OxyMask O2 Adult REF OM-1125-14
Southmedic
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.
Scalpels lot contains non-sterile products labeled as sterile.