BEUDAMED
    FDA Enforcement Class II Terminated

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    Recall: Z-1109-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1109-2015
    Event ID
    70280
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    January 14, 2015
    Classification Date
    February 11, 2015
    Termination Date
    December 4, 2017
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    Reason

    The packages may contain foreign material (black particles).

    Code Info

    Product Code: 400640, Lot numbers: 002146, 018136, 039136, 022136, 143136, 109136, 134136, 053146, 180136, 069146, 080136, 169136, 048146, 086136, 006146, 175136, 063146, 037146, 055146, 032146, 049136, 057136, 195136, 193136, 012146, 082136, 024146, 070136, 088136, 020136, 031146, 035146, 092136, 149136, 170136, 019136, 107136, 016146, 025146, 160136, 090136, 130136, 140136, 030146, 003146, 095136, 059146, 161136, 166136, 068146, 079136, 141136, 046146, 054136, 018146, 105136, 194136, 162136, 036146, 010146, 057146, 058146, 009146, 077136, 011146, 163136, 047146, 133136, 142136, 148136, 122136, 055136, 054146, 078136, 017146, 085136, 050136, 056136, 084136, 108136, 094136, 062146, 091136, 069136, 158136, 106136, 174136, 004146, 089136, 121136, 117136, 051136, 164136, 026146, 118136, 093136, 168136, 179136, 167136, 019146, 123136, 041146, 129136, 005146, 052136, 128136, 116136 & 021136.

    Distribution

    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.

    Quantity

    15,779,607 units