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U.S. Department of Health and Human Services

Class 2 Device Recall CAPNOCHECK

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 Class 2 Device Recall CAPNOCHECKsee related information
Date Initiated by FirmFebruary 14, 2025
Date PostedMarch 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1404-2025
Recall Event ID 96238
510(K)NumberK871133 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductCAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Code Information UDI-DI 35019517062667 Lots 2367264 4120594 3785503 3372540 3291105 3274449 2373071 4225429 3785504 3372541 3292653 3287858 2658411 4236887 3788853 3381687 3294706 3289019 2690517 4236889 3788854 3386807 3296610 3290566 2695046 4256023 3788855 3406654 3297304 3294707 2792606 4256024 3799595 3411359 3297306 3321359 2823742 4256025 3807283 3437865 3297307 3332595 2843746 4269090 3813374 3444606 3300487 3335022 2898265 4269092 3816815 3444607 3300894 3337884 2899311 4296456 3829561 3487626 3302400 3362410 2929198 4296457 3833650 3490725 3303731 3367253 2943659 4296458 3838834 3494347 3304217 3782353 2950547 4296459 3856458 3494348 3304218 3782354 2959836 4296460 3859137 3498521 3304219 3782356 2978300 4301986 3880230 3501365 3308703 3782357 2983686 4301987 3904106 3506535 3314198 3782358 2986391 4301988 3911171 3511053 3314205 3785501 3000742 4301989 3918565 3539360 3316934 4064150 3027404 4313391 3918566 3539361 3318658 4070451 3048157 4313392 3922224 3544089 3367254 4070452 3057565 4397645 3937583 3547811 3370375 4080214 3078619 4397646 3937584 3567400 4100059 4081996 3097350 4397648 3937585 3575787 4100060 4087596 3109127 4397649 3940759 3585974 4102743 4087597 3123384 4397650 3953323 3590226 4123706 4090815 3145330 4397651 3959793 3603780 4137598 4090816 3159020 4397652 3966237 3607017 4164939 4094682 3168379 4397653 3975879 3610650 4169446 4094683 3172848 4397654 3988136 3614224 4169447 4204358 3172849 4397655 3991088 3618131 4183765 4210647 3190273 4397656 3999591 3621151 4183766 4213613 3214132 4397657 4009212 3643871 4193996 4217228 3227502 4397661 4013850 3647957 4193997 4217229 3230971 4397662 4034322 3651290 4236888 4236885 3243790 4397663 4037402 3660704 4437691 4236886 3249030 4397664 4042639 3666830 4437692 4420995 3255107 4397665 4049375 3782349 4446696 4420996 3258815 4397666 4052823 3782350 4446697 4420997 3267952 4397667 4055439 3782351 4446698 4420998 3272253 4397668 4061794 3782352 4446699 4437690 3785502 4397669 4109052 3782355 4446700 /
FEI Number 3012307300
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactCustomer service
763-383-3072
Manufacturer Reason
for Recall		Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
FDA Determined
Cause 2		Process control
ActionOn February 14, 2025, customers were notified via Urgent Medical Device Correction letters. Consignees were instructed to locate and quarantine all affected product within their institution and destroy them. The recalling firm will contact customers who have returned completed response forms identifying affected products within their possession to discuss credit.
Quantity in Commerce175,994 US; 45,223 OUS
DistributionUS Nationwide distribution. International distribution pending.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CCK
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