BEUDAMED
    FDA Enforcement Class II Terminated

    Bivona Aire-Cuf Endotracheal Tube

    Recall: Z-0177-2022 · Reported November 3, 2021

    Enforcement

    Recall Number
    Z-0177-2022
    Event ID
    88512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 3, 2021
    Initiation Date
    August 9, 2021
    Classification Date
    October 27, 2021
    Termination Date
    October 13, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Bivona Aire-Cuf Endotracheal Tube

    Reason

    Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

    Code Info

    SKU 25W080 Lots #'s: 3648874 and 3890459 SKU 25W085 Lot # 3387669 SKU 25W090 Lots #'s 322657 and 3342023 SKU 25W095 SKU 35W080 Lots #'s: 3237503, 3237504, 3263029, 3263030, 3267969, 3276517, 3276518, 3276519, 3301034, 3301035, 3301036, 3301479, 3307931, 3312816, 3312817, 3312818, 3312819, 3315710, 3315711, 3315712, 3346087, 3346088, 3349554, 3350510, 3350511, 3361918, 3361919, 3370120, 3370121, 3370122, 3379494, 3423620, 3433341, 3437242, 3437243, 3437244, 3437245, 3442385, 3450988, 3450989, 3451017, 3454875, 3454876, 3459488, 3459489, 3523718, 3528478, 3536391, 3536392, 3536393, 3536395, 3536398, 3536399, 3540955, 3541009, 3565654, 3572777, 3572790, 3577132, 3577134, 3577142, 3582755, 3582756, 3596290, 3604256, 3604272, 3608155, 3622333, 3622334, 3622336, 3630052, 3637293, 3656655, 3661490, 3661491, 3661492, 3664416, 3664417, 3677633, 3677634, 3677635, 3700907, 3700908, 3700909, 3700910, 3721738, 3721739, 3726299, 3730889, 3748028, 3890125, 3890127, 3890128, 3890129, 3890130, 3890131, 3890132, 3890133, 3890134, 3917895, 3917896, 3926899, 3926900, 3931090, 3933423, 3936455, 3952241, 3952242, 3952243, 3952244, 3952245, 3952246, 3955677, 3962474, 3985139, 3985140, 3985141, 3985142, 3985143, 3985144, 3985145, 3985146, 3991321, 3991322, 4026705, 4026706, 4039134, 4042021, 4042022, 4043952, 4043953, 4047982, 4060251, 4060252, 4063132, 3459490, 3463693, 3463694, 3463695, 3463696, 3472875, 3472876, 3484265, 3484266, 3484267, 3484273, 3484274, 3488047, 3504014, 3507849, 3512360, 3751160, 3751163, 3774410, 3778485, 3778493, 3782472, 3794166, 3800536, 3890117, 3890118, 3890119, 3890120, 3890121, 3890122, 3890123, 3890124, 4063133, 4063134, 4063135, 4063136, 4071990, 4071991, 4080805, 4080806, 4083993, 4089280, 4095958, 4097867, 4105268, 4105269, 3463693. SKU 35W085 Lots #'s: 3218553, 3230635, 3230636, 3238617, 3238618, 3258464, 3312935, 3346089, 3370123, 3437246, 3491405, 3507907, 3517266, 3540956, 3569173, 3590693, 3596299, 3608106, 3677631, 3748025, 3774374, 3870331, 3870332, 3890194, 3890195, 3890196, 3890197, 3901068, 3917865, 3929833, 3931093, 3948979, 3998080, 4015630, 4035792 and 4047987. SKU 35W090 Lots #'s: 3469110, 3904517,4002358, 3504012, 3929861, 4002359, 3552747, 3959226, 4029451, 3700911, 3991328 and 4060253. SKU 35W095 Lots #'s: 3317880, 3839565, 4042023, 3360929 and 4035809

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.

    Quantity

    7136 devices