{ "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": 1 } }, "results": [ { "cfres_id": "49887", "product_res_number": "Z-0424-2007", "event_date_initiated": "2007-01-09", "event_date_posted": "2007-02-15", "recall_status": "Terminated", "event_date_terminated": "2008-09-02", "res_event_number": "37085", "product_code": "FSA", "product_description": "Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172", "code_info": "item KKX053850.0 - models KA1230 (with safety) and KA1240, with production dates of September 2006 through December 2006. The tag on the sling will state the item number and have the year ''06'' hole-punched in the top line ''Y'', and either the month ''09'', ''10'', ''11'' or ''12'' hole-punched in the third line ''M''.", "firm_fei_number": "1419652", "recalling_firm": "Arjo, Inc.", "address_1": "50 Gary Ave Ste A 50 Gary Ave", "address_2": "Ste A", "city": "Roselle", "state": "IL", "postal_code": "60172-1684", "additional_info_contact": "Ms. Traci Giovenco\n800-323-1245", "reason_for_recall": "There is the potential for the slings to come apart, potentially allowing injury to the patient.", "root_cause_description": "Other", "action": "Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.", "product_quantity": "66 slings", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K844976", "K841395", "K860837", "K840997", "K902141", "K780684", "K942807", "K841398", "K930625", "K851844", "K823206", "K811899", "K792601" ], "device_name": "Lift, Patient, Non-Ac-Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.5510", "device_class": "1", "registration_number": [ "9616471", "2247992", "3042158935", "3030733800", "3009544661", "3007802293", "3009265647", "3015772781", "3013675759", "3008685522", "3020225550", "2132280", "3004905643", "3010398927", "3003878287", "2182762", "3008856821", "3014146451", "3007682310", "1000214453", "3014200467", "1054241", "1824206", "3009425497", "3012292104", "3009683397", "3004168774", "1419181", "3016734231", "3007238754", "3010010434", "3013875443", "3004730053", "3013528441", "3015173437", "3006554924", "3012392312", "3005484027", "2531468", "3007309299", "3007710870", "3017264244", "2320762", "3008555994", "1651499", "3011497619", "3013557562", "3005755627", "2531465", "3027517735", "3010359088", "2029188", "2183887", "3023869661", "9681684", "3003781173", "3008941254", "3010840617", "9616091", "3005841027", "3013354832", "3013169808", "3008311431", "3004727093", "3008906627", "3009709183", "3036834029", "3036801251", "3007048017", "3009525805", "3011245426", "3003775119", "3038008630", "3026309274", "3013524663", "3008771621", "1531186", "3021599329", "3007608806", "3010113803", "3042255028", "3043460907", "3026523692", "3007031002", "1058069", "3029906624", "3004976058", "3005753836", "3042657413", "3009407891", "3019865493", "1000406324", "1000153536", "3009327812", "3034538639", "3009491742", "3004034546", "1417592", "3009402404", "3009157571", "3012316249", "3013836619", "3043654660", "3014982520", "3016678950", "3023859", "3027643666", "3004194020", "9616086", "3013318446", "3007479130", "3015005479", "3017278503", "3004615451", "3034694766", "3013685983", "3043624305", "3006619688", "8030903", "3010605276", "3039527731", "1043214", "3010880685", "3005260401", "3008370501", "3007539307", "1041130", "3033790380", "3016674288", "3005748481", "3021256830", "3018050094", "3017869684", "3032368", "1221921", "3007689746", "3001708137", "3019798849", "3016678044", "9710050", "3016590299", "3004137175", "8043351", "3009481053", "3004648937", "3026925581", "3007420694", "3018117722", "1832066", "3001947547", "3036107705", "8030916", "3010472212", "3006891315", "3011495193", "3009955851", "3011647337", "3039318471", "1933441", "3015005470", "3040280511", "3031027436", "3006113262", "3014523858", "3014579161", "1422399", "3017375560", "1225263", "3034520", "3024761165", "3008485769", "1218386", "1055236", "3008406502", "3005202231", "9615386", "3005037196", "3005613467", "3033882216", "3014273557", "3012643605", "3015286905", "9615246", "3012781455", "3033506545", "1319061", "3004730072", "3018229265", "3011574775", "3010067993", "3004461389", "3012137459", "3007005431", "3007231105", "3010509576", "3044744974", "3006206434", "3003063250", "8022890", "3031233916", "3030441550", "3007441619", "3044470904", "3007518069", "1000211739", "3018269545", "3007048057", "3035641505" ], "fei_number": [ "3042158935", "3030733800", "3009544661", "3007802293", "3002913923", "3009265647", "3015772781", "3013675759", "3008685522", "3020225550", "3000719717", "3004905643", "3010398927", "3003878287", "2182762", "3008856821", "3014146451", "3014200467", "1000214453", "1824206", "3009425497", "3012292104", "3009683397", "3004168774", "1419181", "3016734231", "3007238754", "3010010434", "3013875443", "3004730053", "3013528441", "3015173437", "3017968315", "3006554924", "3012392312", "3005484027", "3007309299", "3007710870", "3017264244", "3008555994", "3011497619", "3013557562", "3005755627", "3027517735", "3010359088", "3003350313", "2183887", "3023869661", "3010840617", "3003781173", "3008941254", "3005841027", "3013354832", "3013169808", "3008311431", "1000150534", "3004727093", "3008906627", "3036834029", "3036801251", "3007048017", "3009525805", "3011245426", "3003775119", "3926", "3026309274", "3038008630", "3001600982", "3013524663", "3008771621", "3006291016", "3021599329", "3007608806", "3010113803", "3042255028", "3043460907", "3026523692", "3007031002", "3029906624", "3004976058", "3005753836", "3042657413", "3009407891", "3003040625", "3019865493", "1000406324", "1000153536", "3009327812", "3034538639", "3009491742", "3004034546", "3003769112", "1417592", "1000112877", "3009402404", "3009157571", "3012316249", "3013836619", "3043654660", "3014982520", "3016678950", "3023859", "3027643666", "3004194020", "3013318446", "3007479130", "3015005479", "3017278503", "1000143830", "3004615451", "3034694766", "3013685983", "3043624305", "3006619688", "3002889431", "3010605276", "3039527731", "1043214", "3010880685", "3005260401", "3008370501", "3007539307", "1041130", "3033790380", "3016674288", "3005748481", "3021256830", "1000208827", "3017869684", "3018050094", "1221921", "3007689746", "3001708137", "3019798849", "3016678044", "3016590299", "3004137175", "3002835648", "3009481053", "3004648937", "3026925581", "3007420694", "1000253203", "3018117722", "1832066", "3001947547", "3036107705", "3002655016", "3010472212", "3006891315", "3011495193", "3009955851", "3011647337", "3039318471", "3015005470", "3040280511", "3003080630", "3031027436", "3006113262", "3014523858", "3014579161", "3017375560", "3006662254", "3024761165", "3008485769", "1218386", "3008406502", "3005202231", "1000112968", "3006076154", "3005037196", "3005613467", "3033882216", "3014273557", "3005068474", "3000230206", "3012643605", "3015286905", "3012781455", "1000164498", "3033506545", "1319061", "3004730072", "3018229265", "1000510680", "3011574775", "3010067993", "1000220847", "3004461389", "3012137459", "3007005431", "1000221992", "3007231105", "3010509576", "3044744974", "3006206434", "3003063250", "3031233916", "3030441550", "3007441619", "3044470904", "3007518069", "1000211739", "3018269545", "3002833166", "3007048057", "3035641505" ] } } ] }