{ "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": "109065", "product_res_number": "Z-0005-2013", "event_date_initiated": "2012-07-16", "event_date_posted": "2012-10-02", "recall_status": "Terminated", "event_date_terminated": "2014-01-15", "res_event_number": "61780", "product_code": "LZG", "k_numbers": [ "K032257" ], "product_description": "IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. \nThe device is intended to deliver insulin therapy.", "code_info": "OneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00, 101421-00, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, and 101425-98;   Animas(R) 2020 Insulin Infusion Pumps - Part numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00;   Animas(R) IR 1250 (1200 Plus) Insulin Infusion Pumps -- Part numbers 100250-00, 100251-00, and 100252-00; and   Animas(R) IR 1200 Insulin Infusion Pumps - Part numbers 100200-00, 100201-00, and 100202-00. Serial numbers -- will be provided.", "firm_fei_number": "3002920072", "recalling_firm": "Animas Corporation", "address_1": "200 Lawrence Dr", "city": "West Chester", "state": "PA", "postal_code": "19380-3428", "additional_info_contact": "Jon Mulberg\n610-644-8900", "reason_for_recall": "Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, Animas Corporation, sent an \"IMPORTANT PATIENT NOTIFICATION\" letter dated July 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to examine their insulin pump for wear or damage on a regular basis, as part of their routine process of inspecting their pump. If keypad is worn or damaged, the buttons may not respond as intended. If consignees/customers see any damage or have issues with the keypad, they are to contact Animas through their website at www.animas.com/contact-animas or telephone Animas Customer Technical Support at 1-855-230-7574, or the phone number provided on the back of their insulin pump. Animas carefully investigates all complaints related to the insulin pump keypad.\n\nIf you have any questions contact Animas Customer Technical Support at 1-855-230-7574.", "product_quantity": "236,470", "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.", "openfda": { "k_number": [ "K111669", "K031541", "K001604", "K990801", "K021439", "K023471", "K120206", "K972107", "K240158", "K973044", "K071613", "K090245", "K111353", "K082595", "K991376", "K050760", "K053177", "K900498", "K162296", "K042792", "K210714", "K031373", "K071788", "K022317", "K140439", "K960001", "K884978", "K060876", "K070844", "K133593", "K103825", "K162080", "K122483", "K051041", "K042887", "K192659", "K041318", "K100567", "K223372", "K160056", "K993184", "K041317", "K901588", "K020655", "K141758", "K211575", "K050971", "K073356", "K083225", "K100504", "K022831", "K160482", "K131294", "K013807", "K253534", "K905693", "K963948", "K062323", "K122953", "K063674", "K160252", "K021725", "K241622", "K143189", "K111210", "K082590", "K032257", "K142619", "K030531", "K180045", "K032164", "K050312", "K993012", "K043000", "K063126", "K093364", "K994186", "K013309", "K040676", "K031738", "K080639", "K182630", "K042873", "K022394" ], "registration_number": [ "3010291427", "3012421607", "2029275", "3013636348", "3007007790", "3014585508", "3009515470", "3007939342", "3005627859", "1220477", "1721676", "3010047442", "3007981285", "1313700", "3042027705", "3007710663", "9617604", "3008810357", "9610126", "3006194679", "3027453514", "3016540876", "3011393376", "2032227", "3001058982", "3007871880", "3002806818", "3013756811", "2246552", "9616814", "3009337401", "3020976354", "3015218509", "3008824097", "3006479639", "3010162782", "3005340341" ], "fei_number": [ "3010291427", "3012421607", "3013636348", "3007007790", "3003166194", "3014585508", "3009515470", "3007939342", "3005627859", "1220477", "1721676", "3010047442", "3007981285", "1313700", "3042027705", "3008810357", "3006194679", "3027453514", "3016540876", "3011393376", "1000306431", "3002806559", "3001058982", "3007871880", "3002806818", "3013756811", "2246552", "3003024060", "3004173703", "3009337401", "3020976354", "3015218509", "3008824097", "3006479639", "3010162782", "3002558692", "3005340341" ], "device_name": "Pump, Infusion, Insulin", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }