Z-0177-2022Class II

Bivona Aire-Cuf Endotracheal Tube

Name: Z-0177-2022 Bivona Aire-Cuf Endotracheal Tube
Creator: Smiths Medical ASD Inc.
Published: 2021-08-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-08-09 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Bivona Aire-Cuf Endotracheal Tube on 2021-08-09. FDA classified it as Class II and gives the reason as "Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0177-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-09
Posted: 2021-10-27
Terminated: 2023-10-13
Recalling firm: Abbott Medical
Product: Bivona Aire-Cuf Endotracheal Tube
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Instructions to Consignees 1. Locate and quarantine affected product in your possession. 2. Determine the number of affected devices in your possession and complete the Response Form 3. All affected product must be returned to Sedgwick for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. Instructions to Distributors DISTRIBUTORS: if 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
Quantity in commerce: 7136 devices
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0177-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0177-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-27
Z-0178-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-27

Product code BTR

K792035Class IIFome-Cuf-Wire Re-Enforced, Aire-Cuf WireBivona Medical Technologies / cleared 1979-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)