{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "168818", "product_res_number": "Z-0508-2019", "event_date_initiated": "2018-10-22", "event_date_created": "2018-11-27", "recall_status": "Terminated", "event_date_terminated": "2021-05-06", "res_event_number": "81480", "product_code": "HIF", "k_numbers": [ "K170784" ], "product_description": "PNEUMOCLEAR Heated High-Flow Tube Set\n\nProduct Usage:\nThe Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.", "code_info": "Lots from 4011926 to 4013513 (ALL)", "firm_fei_number": "3001556604", "recalling_firm": "WOM World of Medicine AG", "address_1": "Salzufer 8 8 salzufer", "city": "Berlin", "country": "Germany", "additional_info_contact": "Customer Service\n407-472-0372", "reason_for_recall": "It is possible that the packaging of the product can be damaged by the prongs on the tube set.", "root_cause_description": "Packaging process control", "action": "WOM sent a Recall Notification letter dated October 22, 2018 to the their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to send all in the US recalled products back to:\nW.O.M. WORLD OF MEDICINE USA, Inc.\n4531 36th Street\nOrlando, FL 32811-6527\nWOM contacts for coordinating the shipment of the requested products to Orlando:\nCustomer Service -W.O.M. Orlando\nPhone: +1 407 472 0372\n\nCustomer Service -W.O.M. Orlando\nPhone: +1 407 472 0371\n\nPlease send all recalled products returned to Stryker Venlo/Netherlands back to:\nW.O.M. WORLD OF MEDICINE GmbH\nAlte Poststr. 11\n96337 Ludwigsstadt - Germany\nCustomer Service: +49 30 39981 524", "product_quantity": "124,180 tube sets", "distribution_pattern": "Worldwide Distribution - US in the state of California and country of Netherlands", "openfda": { "k_number": [ "K070651", "K962683", "K950219", "K121336", "K900808", "K171139", "K922777", "K905705", "K232464", "K063367", "K002328", "K934131", "K941438", "K122180", "K980134", "K934926", "K913242", "K871928", "K233020", "K260209", "K061387", "K930192", "K011510", "K230239", "K972675", "K091366", "K172516", "K172835", "K242536", "K812200", "K911479", "K925558", "K973447", "K920986", "K001068", "K231342", "K080852", "K913873", "K913772", "K973432", "K944509", "K983326", "K140263", "K922038", "K014166", "K250388", "K914101", "K153513", "K063546", "K112357", "K992381", "K922244", "K905481", "K000180", "K110294", "K022052", "K963423", "K910983", "K090652", "K911179", "K060723", "K934928", "K132204", "K924481", "K935862", 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"K914401", "K030469", "K845021", "K222901", "K962863", "K111441", "K202799", "K033991", "K925691", "K090456", "K935639", "K912044", "K955393", "K935503", "K033614", "K003703", "K190303", "K930696", "K150068", "K103692", "K102136", "K920205", "K900878" ], "device_name": "Insufflator, Laparoscopic", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.1730", "device_class": "2", "registration_number": [ "1320894", "1450662", "1225798", "1225984", "3004111573", "3015241782", "3002259632", "3002808148", "3027242374", "1017294", "3003755939", "3016727307", "3020704423", "3010383847", "3009988302", "3020746799", "9616088", "3007305485", "2028523", "3010400367", "9611102", "8030607", "3017119401", "2955842", "3017565103", "3003627840", "3007791595", "3012322232", "1064584", "2320762", "3001003398", "3010280860", "1057358", "1531174", "3012883081", "3004605321", "2135348", "3008044552", "3005213560", "3018126215", "1319639", "3008595179", "3015806723", "1450997", 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