Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/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