{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "149774", "product_res_number": "Z-0211-2017", "event_date_initiated": "2015-04-22", "event_date_created": "2016-10-20", "recall_status": "Terminated", "event_date_terminated": "2016-10-25", "res_event_number": "71968", "product_code": "FSY", "product_description": "Knee Arthroscopy Pack\tAMS2610, AMS2610(A, AMS3236,\nPSS2188(A, and PSS2208(A\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot Numbers/Expiration Dates:  63879\t1/23/2014 58286\t3/18/2014 58810\t6/21/2014 62512\t10/18/2014 63024\t12/13/2014 65774\t2/25/2015 68072\t4/17/2015 68548\t4/25/2015 70982\t11/26/2015 73402\t3/14/2016 74837\t3/22/2016 75198\t4/20/2016 67703\t7/1/2016 78551\t7/30/2016 78600\t7/30/2016 68823\t9/11/2016 68713\t9/20/2016 71080\t12/26/2016 72020\t1/10/2017 73647\t1/28/2017 73205\t3/9/2017 73034\t3/23/2017 77621\t7/21/2017 79992\t8/1/2017 77815\t8/11/2017 80859\t8/31/2017 77783\t10/10/2017 75744\t10/21/2017 79326\t1/13/2018", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "additional_info_contact": "Vicki Davis\n406-259-6387", "reason_for_recall": "The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.\n\nConsignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes. \n\nConsignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution. \n\nAMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.\n\nDue to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:\n\nRECALL NOTICE\nMedtronic announced the recall l of Devon Light Glove contained in this kit\nafter it was sealed and sterilized. All other components in the kit are not\naffected by this recall.\n\n1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside\n\n2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.\n\nConsignees should complete the attached Reply Form and fax to AMS at 406-256-9875.\n\nFor any questions about this recall, please call 321-527-7714.\nFor questions regarding this recall call 404-259-6387.", "distribution_pattern": "Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.", "openfda": { "k_number": [ "K896674", "K901830", "K031979", "K132551", "K024132", "K142076", "K965130", "K131893", "K900211", "K030906", "K820681", "K102758", "K982063", "K873786", "K961843", "K780666", "K984611", "K040015", "K973466", "K021585", "K122875", "K943288", "K042382", "K071698", "K132747", "K093010", "K860739", "K140461", "K132307", "K963682", "K083323", "K061317", "K891756", "K944855", "K031068", "K954169", "K083066", "K010716", "K042395", "K002463", "K060802", "K922836", "K904965", "K991527", "K981081", "K915285", "K993242", "K063333", "K140812", "K140460", "K992090", "K902864", "K891757", "K100702", "K072072", "K990656", "K892808", "K914076", "K080857", "K090378", "K070442", "K101537", "K093009", "K120392", "K140930", "K781887", "K974084", "K011693", "K974433", "K040735", "K142984", "K854922", "K771865", "K000639" ], "registration_number": [ "3012272052", "3030558088", "3031700059", "3011574775", "9710585", "3007238566", "3012165496", "9710055", "3026390991", "3025628903", "1000122786", "3042991836", "3042992004", "3015223105", "3017970309", "3007682310", "3007591382", "8010153", "1066635", "3030516433", "1054713", "3029936435", "1836161", "3012092534", "1066270", "3044829820", "3002532594", "3021839632", "1423537", "1043572", "3000286616", "1921846", "9611503", "3031563141", "3010726901", "3035641086", "3020703842", "3006223081", "3011137372", "9617655", "3009129579", "3009542956", "9710098", "3002821232", "3007143268", "1225473", "3006437518", "9680506", "3023808059", "3011644607", "3015131225", "3033527731", "3009028104", "3029970239", "3011580044", "9681407", "3011910987", "3005698350", "9612030", "3010041511", "3027847726", "3042970964", "3009061550", "3015468226", "2031963", "1017294", "3003574554", "1825014" ], "fei_number": [ "3002750084", "3012272052", "3030558088", "3031700059", "3011574775", "3007238566", "3012165496", "3026390991", "3025628903", "3002808335", "1000122786", "3042991836", "3042992004", "3015223105", "3017970309", "3007591382", "3025504317", "3030516433", "1000114111", "3029936435", "3003184737", "3044829820", "3002532594", "1043572", "1000182014", "3000286616", "3002806934", "1921846", "3031563141", "3010726901", "3035641086", "3006125657", "3020703842", "3006223081", "3002975342", "3001237319", "3003779679", "3009129579", "3002939620", "3009542956", "3001236905", "3002821232", "3007143268", "1000125341", "3006437518", "3023808059", "3011644607", "3015131225", "3033527731", "3000957797", "3009028104", "3029970239", "3011580044", "1000214453", "3002957101", "3011910987", "3005698350", "3027847726", "3010041511", "3042970964", "1000396729", "3009061550", "3015468226", "1017294", "3005747797", "3003574554", "1825014", "3002465150" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }