{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113079", "product_res_number": "Z-0443-2013", "event_date_initiated": "2012-08-08", "event_date_posted": "2012-12-10", "recall_status": "Terminated", "event_date_terminated": "2016-08-19", "res_event_number": "63235", "product_code": "DPW", "k_numbers": [ "K944495" ], "product_description": "Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. \n\nAffected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model)\n\nAll the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.", "code_info": "Domestic Distribution: 013053, 013104, 013107, 013124, 013154, 013182, 013193, 014203, 014237, 014248, 014249, 014252, 014253, 014254, 014269, 014276, 014310, 014335, 014339, 014361, 014366, 014376, 014380, 014381, 014382, 014384, 014397, 014401, 014406, 014416, 014424, 014429, 014431, 014443, 014444, 014448, 014454, 014458, 014530, 014532, 014533, 014540, 014542, 014545, 014547, 014551, 014552, 014552, 014553, 014598, 014601, 014604, 014608, 014616, 014654, 014657, 014659, 014660, 014661, 014663, 103077, 105X-600001024, 105X-600001025, 105X-600001026, 105X-600001027, 105X-800001019, 105X-800001022, 105X-800001023, 105X-800001024, 105X-800001026, 105X-800001027, 105X-800001027, 105X-800001028, 105X-800001029, 105X-800001030, 105X-800001031, 105X-E00001001, 105X-E00001002, 105X-E00001003, 105X-E00001004, 105X-E00001005, 105X-E00001007, 105X-E00001008, 105X-E00001009, 105X-E00001010, 105X-E00001011, 105X-E00001012, 105X-E00001013, 105X-E00001014, 105X-E00001016, 105X-E00001017, 105X-E00001018, 105X-E00001019, 105X-E00001020, 105X-F00001000, 105X-F00001001, 105X-F00001002, 105X-F00001003, 105X-F00001004, 105X-F00001005, 105X-F00001005, 105X-F00001006, 105X-F00001007, 105X-F00001008, 105X-F00001009, 105X-F00001010, 105X-F00001011, 105X-F00001012, 105X-F00001013, 105X-F00001014, 105X-F00001015, 105X-F00001016, 105X-F00001017, 105X-F00001018, 105X-F00001020, 105X-F00001021, 105X-F00001022, 105X-F00001023. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify. Foreign distribution: 01301, 013043, 013044, 013045, 013046, 013072, 013076, 013175, 013181, 013183, 013188, 014215, 014386, 014392, 014393, 014456, 014535, 014550, 014551, 014561, 014562, 014563, 105X-800001025, 105X-922001017, 105X-922001018, 105X-922001019, 105X-922001021, 105X-9221020, 105X-923001001, 105X-923001002, 105X-923001003, 105X-923001004, 105X-923001005, 105X-923001006, 105X-923001007, 105X-923001007, 105X-923001009, 105X-923001010, 105X-923001011, 105X-E00001000, 105X-E00001003, 105X-E00001006, 105X-E00001015, 105X-F00001019. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify.", "firm_fei_number": "3020115", "recalling_firm": "Parks Medical Electronics, Inc", "address_1": "19460 SW Shaw St", "city": "Aloha", "state": "OR", "postal_code": "97007-1242", "additional_info_contact": "Tech Support\n888-356-9522", "reason_for_recall": "Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.", "root_cause_description": "Employee error", "action": "The firm, Parks Medical Electronics, Inc., sent an \"IMPORTANT SAFETY ISSUE SERIOUS HEALTH CONSEQUENCE\" letter, dated September 10 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers are advised to order LUER UPGRADE KIT WITH MPI if the Parks device includes a Multi Port Inflator (MPI), and/or order the LUER UPGRADE KIT WITHOUT MPI the Parks device does not have a Multi Port Inflator. While waiting for the kit or its installation, consignees/customers should use extreme caution when hooking up the air supply tubes to the cuff's Luer fittings. For ordering your kit, please call 800-547-6427 option 0.\n\nFor responses, questions or concerns, customer should contact Parks Medical Electronics at 888-356-9522 (Phone), 503-591-9753 (Fax) or send email to support@parksmed.com.", "product_quantity": "349 units (Domestic: 270 units - Foreign: 79 units)", "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela.", "openfda": { "k_number": [ "K760751", "K820742", "K030357", "K213974", "K871490", "K925524", "K972798", "K974285", "K904317", "K970211", "K811246", "K882593", "K820272", "K954397", "K872068", "K912446", "K890828", "K252810", "K840169", "K800151", "K780302", "K031931", "K920844", "K810561", "K875179", "K992387", "K853952", "K150268", "K201114", "K921377", "K821373", "K874885", "K251114", "K970139", "K212065", "K901335", "K882138", "K915550", "K984338", "K972213", "K241583", "K051145", "K023431", "K801802", "K844631", "K183574", "K864259", "K030505", "K922368", "K102433", "K041180", "K932068", "K992529", "K896515", "K223843", "K031091", "K140740", "K930227", "K050601", "K896613", "K150347", "K761288", "K903633", "K251904", "K973198", "K031153", "K912562", "K111730", "K811615", "K152930", "K922669", "K901733", "K913827", "K854500", "K211589", "K860766", "K191388", "K052209", "K973078", "K013803", "K181269", "K040228", "K040909", "K243852", "K812005", "K811376", "K111542", "K172457", "K904792", "K112657", "K892707", "K902088", "K082870", "K861023", "K033424", "K050088", "K905411", "K192966", "K010452", "K872048", "K110438", "K013376", "K102595", "K901015", "K911763", "K011899", "K903625", "K131854", "K200337", "K862841", "K770115", "K260700", "K951486", "K062977", "K132139", "K920333", "K922034", "K850137", "K840522", "K894631", "K903026", "K863210", "K031706", "K982986", "K182494", "K222242", "K862720", "K811616", "K910049", "K791418", "K851057", "K860651", "K002186", "K951369", "K992388", "K110347", "K040654", "K942613" ], "registration_number": [ "8020605", "1000589001", "9615583", "3009507273", "1416980", "9613067", "3015139886", "9611033", "3003993690", "3007427881", "3003647374", "3007014520", "3003144120", "9680933", "3010405299", "1319030", "3003730855", "1047843", "3020115", "9680225", "2183744", "1319639", "2183967", "3043198445", "1221072", "8043564", "1937397", "3006169981", "2434008", "1056553", "1216677", "3010390468", "8010762", "1062741", "3004871905", "1000393132", "1124841", "3003971136", "3017636737", "1820334", "3009265194", "8030885", "2183870", "3015151147" ], "fei_number": [ "1000138054", "3004099094", "3000302153", "1000589001", "3000204839", "3009507273", "3002807138", "1416980", "3015139886", "3003993690", "1000279065", "3007427881", "3003010579", "3003647374", "1000637007", "3007014520", "3010790133", "1000115735", "3010405299", "1319030", "3003730855", "1047843", "3020115", "1000132370", "3003244961", "2183744", "3003171455", "3003079707", "3043198445", "3009649876", "1221072", "1937397", "3006169981", "2434008", "1216677", "3010390468", "1000393132", "3004871905", "3003971136", "3017636737", "1820334", "3009265194", "2183870", "3015151147" ], "device_name": "Flowmeter, Blood, Cardiovascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2100", "device_class": "2" } } ] }