{ "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": "141155", "product_res_number": "Z-0344-2016", "event_date_initiated": "2015-10-13", "event_date_created": "2015-11-30", "recall_status": "Terminated", "event_date_terminated": "2016-09-06", "res_event_number": "72466", "product_code": "FOX", "product_description": "Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher.\r\nmodels 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X\r\nand 1125XE.", "code_info": "Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds, stretchers, and in service kits. This product field action is limited to I.V. Poles distributed between 01/07/2014 - 06/24/2014.  The following I.V. Pole option numbers come affixed to beds and stretchers:  Manufacturer Model Number and Product Description 2035-112-010; Head End Left, 2 Stage I.V. Pole 2035-113-011; Head End Right, 2 Stage I.V. Pole 0785-035-101; 26\", 2 Stage IV Pole Assembly 0785-035-200; 26\", 3 Stage IV Pole Assembly 0785-035-300; 30\", 3 Stage IV Pole Assembly 0785-035-401; 30\", 2 Stage IV Pole Assembly   The following I.V. Pole option numbers ship as service kits.  Manufacturer Service Kit Number and Product Description 1105-035-368; 30\" IV POLE 2 STAGE HE PR 1105-035-367; 30\" IV POLE 2 STAGE HE PL 1105-035-343; 30\" IV POLE 2 STAGE FE PR 1105-035-341; 30\" IV POLE, 2 STAGE HE, PR 1105-035-340; 30\" IV POLE, 2 STAGE FE, PL 1105-035-338; 30\" IV POLE, 2 STAGE FE, PL 1040-035-338; 2-STAGE IV POLEHEAD LT30\" ZM 0785-035-340; 2-STAGE IV POLE,HEAD LT, 30\" 0785-035-341; 2-STAGE IV POLEHEAD RT 30\" 0785-035-343; 2-STAGE IV POLE,FOOT RT, 30\" 1105-035-344; 30\" IV POLE, 3 STAGE FE, PL 1105-035-342; 30\" IV POLE, 3 STAGE HE, PL 1105-035-339; 30\" IV POLE, 3 STAGE FE, PR 1105-035-369; 30\" IV POLE, 3 STAGE HE, PL 1105-035-366; 30\" IV POLE, 3 STAGE HE, PR 0785-035-339; 3-STAGE IV POLE,FOOT RT, 30\" 0785-035-342; 3-STAGE IV POLE,HEAD LT, 30\" 1105-035-644; 26\" IV POLE, 3 STAGE FL 1105-035-642; 26\" IV POLE, 3 STAGE HL 1105-035-639; 26\" IV POLE 3 STAGE FR 1105-035-637; 26\" IV POLE, 3 STAGE HR 0785-035-637; 3-STAGE IV POLE,HEAD RT, 26\" 0785-035-639; 3-STAGE IV POLE,FOOT RT, 26\" 0785-035-642; 3-STAGE IV POLE,HEAD LT, 26\" 1105-035-643; 26\" IV POLE, 2 STAGE FR 1105-035-641; 26\" IV POLE, 2 STAGE HR 1105-035-640; 26\" IV POLE, 2 STAGE FL 1105-035-638; 26\" IV POLE, 2 STAGE HL 0785-035-638; 2-STAGE IV POLE,HEAD LT, 26\" 0785-035-640; 2-STAGE IV POLE,FOOT LT, 26\" 0785-035-641; 2-STAGE IV POLE,HEAD RT, 26\" 0785-035-643; 2-STAGE IV POLE,FOOT RT, 26\" 2035-112-000; IV POLE - 2 STAGE H/E 2035-113-000; DUAL H/E 2 STAGE IV POLE OPT", "firm_fei_number": "1831750", "recalling_firm": "Stryker Medical Division of Stryker Corporation", "address_1": "3800 E Centre Ave", "city": "Portage", "state": "MI", "postal_code": "49002-5826", "additional_info_contact": "Stryker Customer Service\n800-327-0770", "reason_for_recall": "It was identified by a customer complaint that some I.V. poles were\r\nretracting/lowering from an extended position to the low height unexpectedly. An\r\ninvestigation was initiated which identified that the I.V. Latch Housing was\r\nnonconforming. potential hazards:\r\n\" Suspended I.V. pole retracts unexpectedly\r\n\" Suspended I.V. pole retracts unexpectedly with pump/bags attached", "root_cause_description": "Process control", "action": "On 10/13/2015, URGENT MEDICAL DEVICE NOTIFICATION letters were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. \r\nIf you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).", "product_quantity": "19,876", "distribution_pattern": "Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore.", "openfda": { "k_number": [ "K895776", "K880537", "K852937", "K820963", "K980336", "K946201", "K770422", "K823270", "K961470", "K883133", "K821405", "K925066", "K964782", "K870473", "K864753", "K850245", "K952196", "K852329", "K861838", "K900981", "K845031", "K854082", "K880538", "K884341", "K852300", "K893597", "K960027", "K882493", "K860468", "K950367", "K912010", "K850671", "K872729", "K932498", "K883260", "K944580" ], "registration_number": [ "3013764800", "", "1825014", "3014643275", "3004755235", "9617277", "3015967359", "3037012186", "3007123908", "3003019064", "3001644167", "3015772781", "3001452523", "1043646", "1318843", "3012268721", "3018094310", "3001040506", "3043236281", "9614609", "3005694091", "3004905643", "3006984916", "3003908598", "2182762", "3007309323", "9617566", "3043479340", "3029929134", "2529571", "8021995", "1526863", "3005772723", "1824206", "3009425497", "3044563261", "3007029061", "3009683397", "3036470679", "3016734231", "3004548776", "3010595915", "1518293", "3012345110", "3011063460", "3003823002", "3008719017", "3010157088", "9613910", "3008386649", "2936485", "8020785", "3003749961", "8043933", "3006721341", "3010303097", "3008321254", "3006897028", "3011191255", "1722070", "3006061749", "3004634242", "3005034064", "3007417753", "3011468686", "1220908", "3013144977", "3002808466", "3003781173", "1058031", "3008879776", "3016832577", "3010465331", "1928237", "3038241934", "3007518294", "3018783526", "3008311431", "3031082325", "3003464075", "3005024024", "3009567010", "3013495708", "3013875526", "3003775119", "3005182235", "1221934", "3006897996", "3007499787", "3013524663", "3020188747", "2085602", "3045978136", "3015526491", "2124215", "3010817335", "3005053560", "1921846", "3008729547", "3008881803", "3043460907", "2921578", "1423662", "8043685", "3011237770", "3006342679", "3005369776", "3009407891", "3003674698", "3015527824", "9681702", "3004024088", "3027847726", "3020331900", "3010047033", "1000153536", "3009327812", "3034729907", "3015465361", "3024088964", "3043749706", "2182536", "9618009", "8020347", "3032916632", "3004034546", "3008351005", "2133786", "3036716847", "3007160937", "1417592", "3011506263", "1836161", "9611451", "3012316249", "3013875599", "3013319212", "1423507", "3005555653", "3001675293", "3008363441", "3006697241", "3014982318", "3008808123", "1423537", "1523530", "3027643666", "3007662999", "3015439135", "2134265", "3017607477", "3004194020", "3009674182", "1450997", "3013182765", "9681599", "1649914", "3009273990", "1526605", "3013685983", "3002808157", "3009282549", "3010605276", "3014810929", "2523676", "3038632739", "9616567", "3013846070", "3030681105", "3014421917", "8022787", "3042898206", "9615896", "3006795832", "3013184907", "3011816755", "3010675897", "2518399", "3019505063", "1416980", "3010373263", "3007203968", "3023189540", "3010885402", "2023337", "9680168", "3005380088", "3006128321", "3007734888", "2244019", "3015612252", "3009247326", "3010987649", "3013041594", "3033813905", "1724810", "3033814356", "3004824601", "2020601", "3007305485", "3007886583", "1320894", "3011537487", "3010024164", "9615817", "3007508552", "3004636440", "3007753695", "3016053921", "3025369303", "3035710892", "3011659880", "3014220748", "1831750", "3011390406", "1523574", "8030607", "3009596133", "3012706378", "3031582440", "3031562615", "3008253300", "2024242", "3007019343", "8022752", "2518422", "3003123807", "3027486074", "3038191348", "3008058406", "2133641", "9680933", "3014555455", "3020160672", "3006260740", "3042940623", "3004932888", "8022077", "3012579728", "3013868968", "3014273557", "3003152976", "3023272766", "3026818268", "3003587684", "3011526299", "9615393", "3006786907", "3017181414", "3015058854", "3032171543", "3019315696", "2521402", "3006553621", "2024168", "3015286905", "3013298431", "3005214422", "3015414875", "3004957206", "9681860", "3033506545", "3014293077", "3005285078", "3012272052", "3008791328", "3038623066", "3009028104", "1319639", "3022978896", "2435946", "3011475060", "2518157", "3042262500", "3009591865", "8022890", "3012798826", "1045254", "3008114965", "9611665", "2027804", "3004491689", "1623486", "1649660", "2024022", "3010394125", "3011011193", "3033011342", "3021073836" ], "fei_number": [ "3013764800", "", "1825014", "6425", "3014643275", "3004755235", "3015967359", "3037012186", "1000121370", "3003019064", "3007123908", "3001644167", "3015772781", "3001452523", "1043646", "1318843", "3001451796", "3012268721", "3001451571", "3001040506", "3018094310", "3043236281", "3006984916", "3005694091", "3004905643", "3003908598", "2182762", "3003327839", "3007309323", "3043479340", "3029929134", "1526863", "3005772723", "1824206", "3009425497", "3044563261", "3007029061", "3009683397", "3036470679", "3016734231", "3004548776", "3010595915", "1518293", "3012345110", "3011063460", "3003823002", "3008719017", "3010157088", "3008386649", "2936485", "3003749961", "3006721341", "3010303097", "3008321254", "3003057333", "3006897028", "3011191255", "3005034064", "3006061749", "3004634242", "3002807095", "3007417753", "3011468686", "1220908", "3013144977", "3002808466", "3003781173", "3038241934", "3008879776", "3016832577", "3010465331", "3003491392", "1928237", "3007518294", "3018783526", "3003244771", "3008311431", "3003464075", "3031082325", "3005024024", "3009567010", "3013495708", "3013875526", "1000138054", "3003775119", "3926", "3005182235", "1221934", "3006897996", "3007499787", "3002095335", "1000295034", "3013524663", "3020188747", "3045978136", "3015526491", "2124215", "3010817335", "3005053560", "1921846", "3008729547", "3008881803", "3043460907", "3000204692", "2921578", "3005612924", "3004574120", "3008002452", "3011237770", "3006342679", "3005369776", "3009407891", "3003674698", "3015527824", "3004024088", "3027847726", "3020331900", "3010047033", "3000215273", "3009327812", "1000153536", "3015465361", "3034729907", "3024088964", "3043749706", "2182536", "3032916632", "3004034546", "3008351005", "3007160937", "3036716847", "1417592", "3011506263", "3000210616", "3012316249", "3013875599", "3006363476", "3013319212", "3002619595", "3000203466", "3005555653", "3001675293", "3008363441", "3006697241", "3014982318", "3008808123", "1523530", "3027643666", "3007662999", "3015439135", "1000221960", "3002750084", "3009674182", "3017607477", "1450997", "1000117260", "3013182765", "3004194020", "3009273990", "1526605", "3013685983", "3002808157", "3009282549", "3003081151", "3010605276", "3014810929", "3001236905", "2523676", "3002732397", "3013846070", "3038632739", "3030681105", "3014421917", "3042898206", "3006795832", "3013184907", "3011816755", "3010675897", "2518399", "3019505063", "1416980", "3010373263", "3007203968", "3023189540", "3010885402", "2023337", "3001665800", "1000125732", "3005380088", "3006128321", "3007734888", "2244019", "3015612252", "3009247326", "3010987649", "3013041594", "3033813905", "3033814356", "3004824601", "2020601", "3007305485", "3007886583", "3007508552", "3011537487", "3010024164", "3004636440", "3007753695", "3002806988", "3016053921", "3025369303", "3035710892", "3011659880", "3014220748", "1831750", "3011390406", "1523574", "3009596133", "3012706378", "3031582440", "3031562615", "3008253300", "2024242", "3007019343", "3003749234", "2518422", "3003123807", "3027486074", "3038191348", "3008058406", "3006260740", "1000137528", "3014555455", "3020160672", "3042940623", "3004932888", "3012579728", "3013868968", "3014273557", "3003152976", "3005947796", "3023272766", "3000171642", "3026818268", "3003587684", "3011526299", "3006786907", "3017181414", "3011343761", "3015058854", "3003190524", "3019315696", "2521402", "3006553621", "2024168", "3015286905", "3013298431", "3005214422", "3015414875", "3032171543", "3033506545", "3004957206", "3002808508", "3014293077", "3003110144", "3005285078", "3012272052", "3008791328", "3038623066", "3009028104", "1000484507", "3022978896", "3002963732", "3011475060", "3009291251", "2518157", "3042262500", "3009591865", "3012798826", "1000637007", "3008114965", "1045254", "3004491689", "1623486", "3006509795", "2024022", "3010394125", "3011011193", "3033011342", "3021073836" ], "device_name": "Stand, Infusion", "medical_specialty_description": "General Hospital", "regulation_number": "880.6990", "device_class": "1" } } ] }