{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188883", "product_res_number": "Z-0177-2022", "event_date_initiated": "2021-08-09", "event_date_created": "2021-10-27", "recall_status": "Terminated", "event_date_terminated": "2023-10-13", "res_event_number": "88512", "product_code": "BTR", "k_numbers": [ "K792035" ], "product_description": "Bivona Aire-Cuf Endotracheal Tube", "code_info": "SKU 25W080 Lots #'s: 3648874 and 3890459\nSKU 25W085 Lot # 3387669\nSKU 25W090 Lots #'s 322657 and 3342023\nSKU 25W095\nSKU 35W080 Lots #'s: 3237503, 3237504, 3263029, 3263030, 3267969, 3276517, 3276518,\n3276519, 3301034, 3301035, 3301036, 3301479, 3307931, 3312816, 3312817, 3312818, 3312819, 3315710, 3315711, 3315712, 3346087, 3346088, 3349554, 3350510, 3350511,\n3361918, 3361919, 3370120, 3370121, 3370122, 3379494, 3423620, 3433341, 3437242,\n3437243, 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,\n3630052, 3637293, 3656655, 3661490, 3661491, 3661492, 3664416, 3664417, 3677633, 3677634, 3677635, 3700907, 3700908, 3700909, 3700910, 3721738, 3721739, 3726299,\n3730889, 3748028, 3890125, 3890127, 3890128, 3890129, 3890130, 3890131, 3890132,\n3890133, 3890134, 3917895, 3917896, 3926899, 3926900, 3931090, 3933423, 3936455,\n3952241, 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, \n4060252, 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. \nSKU 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,\n3890196, 3890197, 3901068, 3917865, 3929833, 3931093, 3948979, 3998080, 4015630,\n4035792 and 4047987.\nSKU 35W090 Lots #'s: 3469110,\t3904517,4002358, 3504012, 3929861, 4002359, 3552747,\t3959226, 4029451, 3700911, 3991328 and 4060253.\nSKU 35W095 Lots #'s: 3317880,\t3839565, 4042023, 3360929 and 4035809", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "Mr. Dave Halverson\n763-383-3310", "reason_for_recall": "Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.", "root_cause_description": "Process control", "action": "Instructions to Consignees \n1. Locate and quarantine affected product in your possession.\n2. Determine the number of affected devices in your possession and\ncomplete the Response Form \n3. All affected product must be returned to Sedgwick for processing.\nA pre-paid return shipping label will be sent to you when the Response\nForm is returned indicating whether impacted devices are in your\npossession. \nInstructions to Distributors DISTRIBUTORS: \nif you have distributed potentially affected product to your customers, please immediately notify them of this Recall and instruct them to return the Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only", "product_quantity": "7136 devices", "distribution_pattern": "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\nBermuda, Canada, Germany, Denmark, Great Britain and Italy.", "openfda": { "k_number": [ "K945455", "K871632", "K080339", "K931735", "K896181", "K110269", "K000045", "K861461", "K871263", "K830352", "K081086", "K253437", "K852025", "K842464", "K930179", "K932561", "K843936", "K080170", "K213028", "K131254", "K961837", "K842635", "K861463", "K880487", "K840973", "K932647", "K931164", "K945745", "K170234", "K954585", "K830631", "K812880", "K930150", "K781808", "K190878", "K920900", "K082520", "K925855", "K161813", "K791046", "K150603", "K821180", "K934465", "K874679", "K083119", "K223130", "K990098", "K951697", "K021044", "K991580", "K844746", "K121028", "K190630", "K040657", "K032112", "K862347", "K870387", "K810763", "K141939", "K243785", "K844564", "K810151", "K833197", "K050803", "K811888", "K181880", "K925506", "K895132", "K903876", "K771197", "K051993", "K093135", "K940041", "K792035", "K041917", "K251499", "K842558", "K171411", "K110962", "K880960", "K080105", 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