{ "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": "94089", "product_res_number": "Z-0132-2011", "event_date_initiated": "2010-05-05", "event_date_posted": "2010-10-22", "recall_status": "Terminated", "event_date_terminated": "2013-03-28", "res_event_number": "56610", "product_code": "DPW", "k_numbers": [ "K903625" ], "product_description": "PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146:\nModel 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device.\nModel 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device\nModel 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices", "code_info": "78050 Starting with lot 1335050157 exp date 2010-04 Ending with lot 1469100138 exp date 2015-03  78060 Starting with lot 1335050222 exp date 2010-04 Ending with lot 1470100140 exp date 2015-03   75010 Starting with lot 1337050271 exp date 2010-05 Ending with lot 1469100139 exp date 2015-03", "firm_fei_number": "2183477", "recalling_firm": "Escalon Medical Corp", "address_1": "2440 S 179th St", "city": "New Berlin", "state": "WI", "postal_code": "53146-2149", "additional_info_contact": "262-821-9182", "reason_for_recall": "The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall involes: Model 78050 18 Gauge PD Access Vascular Access Device, Model 78060 Extended 18 Gauge PD Access Vascular Access Device, Model 75010 18 Gauge SmartNeedle Vascular Access Devices with Expiration Da", "root_cause_description": "Package design/selection", "action": "Escalon Vascular Access issued an \"Urgent: Recall\" letter dated May 5, 2010 to customers. The letter identified the affected product being recalled, described the problem, and the actions to be taken.. Consignees were recommended to immediately examine their inventory, quarantine the product, notify their customers, and return product affected. They also advised them that if they have further distributed the product, to please identify the customers and notify them at once of the product recall. Replacement product can be ordered from Vascular Solutions, Inc at 888-240-6001. Customer service can be contacted at 800-676-0043.", "product_quantity": "188,375", "distribution_pattern": "Worldwide Distribution: USA, including the states of AL, AR, AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD.MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, MN, NY, NC, ND, OH, OK OR, PA, RI, SC, SD,TN, TX UT, VA, WA, WV, and WI, and the countries of: Australia, Austria, Bahamas, Canada, Colombia, Denmark, England, Germany, Greece, Hong Kong, Italy, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, and Switzerland.", "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" } } ] }