{ "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": "175870", "product_res_number": "Z-0191-2020", "event_date_initiated": "2019-08-16", "event_date_created": "2019-10-24", "recall_status": "Terminated", "event_date_terminated": "2020-09-25", "res_event_number": "83599", "product_code": "FQH", "k_numbers": [ "K080779" ], "product_description": "Irrisept Wound Debridement and Cleansing System. 12 units per case.", "code_info": "Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30", "firm_fei_number": "3005706359", "recalling_firm": "IrriMAX Corporation", "address_1": "1665 Lakes Pkwy", "city": "Lawrenceville", "state": "GA", "postal_code": "30043-5881", "additional_info_contact": "844-477-4778", "reason_for_recall": "Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.", "root_cause_description": "Process control", "action": "Irrimax Corporation notified customers on about 08/16/2019 via \"URGENT: MEDICAL DEVICE RECALL\" letter. The letter informed customers that the recall was due to the potential of a defect in the sterile pouch seal, which may result in a lack of sterility assurance, and that the seal defect is not easily visible upon inspection of the pouch. \n\nInstructions to customers included, that within 10 business days of receiving the recall notification, they are to discontinue use of the recalled product (labeled lot numbers 19CAB939 or 19DAB431), complete and return the attached Recall Return Response Customer Acknowledgement and Receipt for to Irrimax by email (customercare@irrimax.com) or mail (Irrimax Corporation, 1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043), and arrange to return any unused affected product by following the Product Return Instructions provided. \n\nDistributors were instructed to discontinue use of the recalled product (labeled lot numbers 19CAB939 or 19DAB431), quarantine any inventory from the recalled lots to ensure product will no longer be distributed, complete and return the attached Recall Return Response Customer Acknowledgement and Receipt for to Irrimax by email (customercare@irrimax.com) or mail (Irrimax Corporation, 1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043), and provide a customer distribution list with customer, name, address, telephone numer and email address (contact information) and send to Irrimax via email (customercare@irrimax.com) by August 23, 2019. Irrimax will send the customer a letter and follow-up with the customer to return all unused product. Additionally, distributors were asked to return recalled product in inventory by following the Product Return Instructions provided.\n\nQuestions can be directed to customercare@irrimax.com by email or toll free 1-844-477-4778.", "product_quantity": "1,031 cases (12,372 units)", "distribution_pattern": "Nationwide distribution to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.", "openfda": { "k_number": [ "K253996", "K202071", "K113312", "K022613", "K110958", "K810185", "K011612", "K221504", "K922083", "K111313", "K854737", "K874504", "K972551", "K210536", "K012464", "K970916", "K983135", "K231023", "K830386", "K143115", "K253445", "K874022", "K021813", "K913568", "K220759", "K210987", "K991383", "K080779", "K082858", "K942886", "K973803", "K974568", "K926337", "K951666", "K033590", "K192349", "K220964", "K060782", "K202222", "K213616", "K222804", "K873466", "K813475", "K090848", "K973485", "K854543", "K790811", "K972069", "K161165", "K933742", "K813607", "K072404", "K820661" ], "registration_number": [ "3010701807", "3014118821", "3020745223", "3007502289", "3006535925", "1526534", "2245304", "8043750", "3002807315", "1054241", "2320762", "3010361494", "3010536692", "1043729", "2528981", "9614209", "3014620201", "1060680", "3010034780", "9681260", "3010400865", "3022320321", "3003477135", "3030535035", "3015173212", "3012964172", "3037027197", "3007177643", "3043604863", "2020601", "2435119", "3011683674", "3004932373", "3017540705", "1054811", "3005941719", "3007366790", "3012130008", "1526439", "1721676", "1649518", "1424263", "8044091", "1000121056", "1422634", "3007997036", "1643264", "1055236", "3031571797", "3005173255", "3014258951", "1423507", "9615063", "3038503932", "3012497308", "3008788129", "2648623", "3004837686", "3008812251", "3025376090", "2648920", "3042172872", "2183613", "3010305275", "3003903031", "3009125070", "3002808022", "2648666", "3013557562", "3007594734", "3009217531", "1043214", "1058584", "9617429", "3002807310", "3010667677", "3010872518", "3010041511", "3038472982", "9610614", "3003587189", "3010531069", "3006611221", "8043484", "3007156625", "3012649202", "3004365956", "3009762450", "3035366890", "3045076544", "3007829657", "3032611331", "1057196", "3011137372", "3003814961", "2649614", "3014351477", "2027148", "3008114965", "3004380247", "2011171", "3004464325", "3043622938", "2244478", "2184009", "1420032", "3012535730", "9616684", "3015967359", "1020279", "1417411", "1526711", "3012494290", "9610711", "3002907620", "2242352", "1724474", "1319660", "3005083075", "3012797688", "1647149", "3005099803", "3013440400", "3013530403", "3030733800", "1718850", "3021784063", "3010273872", "3007125392", "3015542154", "1649139", "3007225330", "1423662", "1036836", "1417519", "3005706359", "9617155", "1018470", "3016678045", "3017252917", "2029275", "3003955307", "2025102", "1526350" ], "fei_number": [ "3010701807", "3014118821", "3020745223", "3007502289", "3006535925", "1526534", "1000132037", "3001236277", "2245304", "3002807315", "3010361494", "3003821398", "3010536692", "1043729", "2528981", "3014620201", "3003040625", "3010034780", "3010400865", "3022320321", "3003477135", "3030535035", "3003094851", "3015173212", "3012964172", "3000215273", "3037027197", "1000114185", "3007177643", "3002807111", "3043604863", "2020601", "2435119", "3011683674", "3004932373", "3017540705", "1000306431", "3012130008", "1526439", "1721676", "1000121056", "3007997036", "1000219637", "1643264", "3031571797", "3002808194", "3005173255", "3014258951", "3038503932", "3012497308", "1000306139", "3002806725", "3008788129", "2648623", "3004837686", "3025376090", "3004857377", "3042172872", "2183613", "3010305275", "3003903031", "3009125070", "3008002452", "3002808022", "2648666", "3013557562", "3007594734", "3009217531", "1043214", "1000112877", "3004949275", "3002807310", "3002406063", "3010667677", "3003015552", "3010872518", "3002948288", "3010041511", "1000112968", "3038472982", "3002807917", "3003587189", "3010531069", "3008133910", "3002807584", "3012649202", "3004365956", "1000140478", "3007282753", "1000136269", "1000514656", "3009762450", "3035366890", "3045076544", "3002913962", "3007829657", "3032611331", "3003814961", "2649614", "3014351477", "2027148", "3008114965", "3004380247", "2011171", "3004464325", "3043622938", "3002807634", "3002806565", "1420032", "3002806920", "3012535730", "1000345108", "3015967359", "1020279", "1417411", "1526711", "1000208624", "3012494290", "3002907620", "2242352", "3005083075", "3012797688", "1000116158", "3005099803", "3013440400", "3013530403", "3030733800", "1718850", "3021784063", "3010273872", "3007125392", "3015542154", "3007225330", "3002808293", "1036836", "1417519", "3005706359", "1018470", "3016678045", "1000136478", "3017252917", "3003955307", "3005747797", "1526350" ], "device_name": "Lavage, Jet", "medical_specialty_description": "General Hospital", "regulation_number": "880.5475", "device_class": "2" } } ] }