{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196064", "product_res_number": "Z-0096-2023", "event_date_initiated": "2022-08-29", "event_date_posted": "2022-10-17", "recall_status": "Terminated", "event_date_terminated": "2023-10-19", "res_event_number": "90855", "product_code": "CAE", "product_description": "Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg\n\nModel Number: 8003000", "code_info": "UDI-DISingle unit: 5030267073511\nUDI-DICase: 05030267046959\nLot code: 32204071", "firm_fei_number": "1000120301", "recalling_firm": "Intersurgical Inc", "address_1": "6757 Kinne St", "city": "East Syracuse", "state": "NY", "postal_code": "13057-1215", "additional_info_contact": "SAME\n315-451-2900", "reason_for_recall": "Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient", "root_cause_description": "Under Investigation by firm", "action": "Intersurgical Inc. issued Urgent Medical Device Recall Letter via email on 08/29/2022 and \nvia certified first-class mail to Distributors. Letter states reason for recall, health risk and action to take: The recall extended to the user level. \nRecall Instructions:\ni. Immediately discontinue use and quarantined any stock with the product/lot number described above in this recall notification.\nii. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you.\niii. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST.\ni. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form:\nii. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com.\niii. The subject line should contain your Company name and RGA number.\n1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return.\n\niv. Intersurgical will credit your account when the product is received.\nv. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form.\nvi. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com.\nvii. The subject line should contain your Company name and Intersurgical Recall.\n\nContact :315-451-2900 ext. 500 or email: kcambpell@intersurgicalinc.com.", "product_quantity": "340 pieces", "distribution_pattern": "OH, TN, TX", "openfda": { "k_number": [ "K960240", "K833482", "K892123", "K850248", "K922748", "K033189", "K833328", "K860949", "K810099", "K821308", "K760488", "K950613", "K855137", "K953400", "K955721", "K812822", "K810651", "K860780", "K842605", "K892053", "K841429", "K033186", "K874412", "K904834", "K021634", "K770001", "K844873", "K862199", "K800881", "K891586", "K861054", "K881065", "K130304", "K854029", "K810123", "K830767", "K791799", "K861482", "K831078", "K832435", "K883593", "K841120", "K933760", "K913680", "K780601", "K822727", "K891926", "K820709", "K832512", "K936134", "K871403", "K832471", "K810069", "K820512", "K890566", "K861540", "K880241" ], "registration_number": [ "3012701990", "3027605742", "3008264111", "3015191173", "3030656972", "3022568093", 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