BEUDAMED
    FDA Recall Terminated

    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003

    Recall: Z-2238-2017 · Initiated May 10, 2017

    Recall

    Recall Number
    Z-2238-2017
    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

    Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003

    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