{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 106 } }, "results": [ { "cfres_id": "46717", "product_res_number": "Z-0079-2007", "event_date_initiated": "2006-05-05", "event_date_posted": "2006-10-28", "recall_status": "Terminated", "event_date_terminated": "2006-11-02", "res_event_number": "35745", "product_code": "GEH", "k_numbers": [ "K053436" ], "product_description": "CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.", "code_info": "Lot: 50515, 50602, 50609", "firm_fei_number": "3008592544", "recalling_firm": "ATS Medical, Inc.", "address_1": "3905 Annapolis Ln N Ste 105 3905 Annapolis Ln N", "address_2": "Ste 105", "city": "Minneapolis", "state": "MN", "postal_code": "55447-5473", "reason_for_recall": "Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.", "root_cause_description": "Other", "action": "Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.", "product_quantity": "219 units", "distribution_pattern": "Nationwide-ATS Medical distirubted devices to hospitals located in the following states IN, KS, MO, TX. There may be other US distributors of this product.", "openfda": { "k_number": [ "K152668", "K964047", "K011708", "K991792", "K973686", "K152337", "K242288", "K181153", "K011950", "K760742", "K021261", "K964971", "K980739", "K892237", "K221897", "K991517", "K872796", "K926464", "K953637", "K031117", "K083493", "K101825", "K904421", "K193619", "K171626", "K042667", "K162599", "K260377", "K881349", "K203032", "K050347", "K160994", "K243245", "K032333", "K170810", "K112072", "K243487", "K982280", "K991272", "K940140", "K062175", "K090978", "K240457", "K971216", "K061510", "K172041", "K190651", "K103310", "K111042", "K111859", "K935010", "K070482", "K130599", "K234002", "K051052", "K073533", "K140058", "K813024", "K912529", "K024009", "K190194", "K021211", "K152329", "K261068", "K781956", "K160669", "K880416", "K980668", "K210310", "K040809", "K810409", "K934261", "K010991", "K161202", "K002615", "K242625", "K142441", "K180211", "K201183", "K252903", "K954872", "K060859", "K203024", 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"medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4350", "device_class": "2" } } ] }