BEUDAMED
    FDA Recall Terminated

    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

    Recall: Z-2239-2017 · Initiated May 10, 2017

    Recall

    Recall Number
    Z-2239-2017
    Event Number
    77282
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    BYG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 10, 2017
    Posted
    May 24, 2017
    Terminated
    August 27, 2021
    Address
    7900 Triad Center Dr, Ste 400, Greensboro, NC, 27409-9076

    Description

    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

    Action

    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.

    Distribution

    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam