{ "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": "210320", "product_res_number": "Z-0276-2025", "event_date_initiated": "2024-09-26", "event_date_posted": "2024-10-30", "recall_status": "Open, Classified", "res_event_number": "95451", "product_code": "CAE", "product_description": "KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.\nModel/Catalog Number: KKLTSD4325", "code_info": "UD-DI: 00612649212746 (Shipper Label); 00612649212753 (Piece Label)", "firm_fei_number": "1824226", "recalling_firm": "King Systems Corp. dba Ambu, Inc.", "address_1": "15011 Herriman Blvd", "city": "Noblesville", "state": "IN", "postal_code": "46060-4253", "additional_info_contact": "Sanjay Parikh\n1-800-2628462", "reason_for_recall": "Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.", "root_cause_description": "No Marketing Application", "action": "King Systems issued Urgent Field Safety Notice on 9/26/624 via email/Certified Mail. Letter states reason for recall, health risk and action to take:\nYou must discontinue use and dispose of King LTS-D\" Disposable Laryngeal Tube pediatric sizes and identify alternative devices for appropriate airway management.\nWithin one month of receipt of this notice, please provide return response for this Field Safety Notice.\n\nThis Notice needs to be passed on to all those who might concern within your organization where the devices could have been transferred.\nPlease transfer this notice to other organizations on which this action has an impact.\nPlease maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.\nPatient safety remains our highest priority. If you have additional questions regarding this information, please contact your local Ambu-King Systems sales representative.\n\nShould you have additional questions, please do not hesitate to contact Tammy Feyerherm at tfey@ambu.com.", "product_quantity": "36727 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K841120", "K021634", "K855137", "K871403", "K831078", "K791799", "K780601", "K822727", "K821308", "K820709", "K892053", "K810123", "K033189", "K812822", "K883593", "K854029", "K810099", "K874412", "K953400", "K820512", "K936134", "K922748", "K810069", "K862199", "K913680", "K891926", "K842605", "K860780", "K800881", "K844873", "K832512", "K033186", "K933760", "K950613", "K891586", "K832471", "K881065", "K861482", "K833328", "K892123", "K770001", "K832435", "K955721", "K810651", "K130304", "K830767", "K960240", "K850248", "K760488", "K861054", "K861540", "K880241", "K890566", "K833482", "K841429", "K904834", "K860949" ], "registration_number": [ 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