BEUDAMED
    FDA Enforcement Class II Terminated

    Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology.

    Recall: Z-0504-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0504-2015
    Event ID
    69658
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    September 3, 2014
    Classification Date
    December 4, 2014
    Termination Date
    August 14, 2017
    Address
    4024 Stirrup Creek Dr, N/A, Durham, NC, 27703-9000, United States

    Description

    Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology.

    Reason

    Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.

    Code Info

    Product No. 043128, Lot # 02E1200719, 02E1200720, 02E1201281, 02F1200964, 02K1201946, 02E1201808, 02E1203097, 02G1300256, 02G1301048, & 02M1201691; Product No. 403133, Lot # 02E1201282, 02K1201948, 02F1200965, 02L1201194, 02M1200230, & 02F1302063; Product No. 031-28, Lot # 02D1202234, 02A1202383, 02A1202382, 02B1201069, 02D1200247, 02D1200248, 02D1201944, 02D1202274, 02D1202733, 02D1202236, 02D1202734, 02D1202735, 02D1202233, 02G1200664, 02G1200678, 02G1201016, 02G1201698, 02F1200961, 02G1200676, 02M1200585, 02L1200927, 02M1200749, 02M1201693, 02A1300194, 02A1300457, 02D1301655, 02D1301191, 02D1300864, 02D1301192, 02D1302730, 02F1301742, 02E1302765, 02F1300739, 02F1302062, & 02D1200249; Product No. 031-28F, Lot # 02E1200717, 02K1201947, 02F1200962, & 02E1202197; Product No. 031-33, Lot # 02E1200718, 02A1202384, 02E1202198, 02F1200963, 02G1200666, 02J1202240, 02M1200584, 02M1200748, 02M1201771, 02D1302731, 02A1300458, 02B1300718, & 02M1201692; Product No. 031-33J, Lot # 02D1202258, 02D1202260, 02D1202259, 02D1202261, 02E1201563, 02E1201279, 02E1203866, 02M1200747, 02B1300717, 02B1301203, 02E1301554, 02B120342, 02J1201473, 02J1202736, 02F1201179, & 02M1200057.

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.

    Quantity

    3,193,548 ea