{ "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": "149618", "product_res_number": "Z-0149-2017", "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": "Basic Tray, Kit part numbers AMS1199(A and PSS1559(A \nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot Numbers/Expiration Dates:  56958\t5/29/2016 56991\t6/4/2016 57637\t7/5/2016 57788\t7/10/2016 59063\t1/22/2016 59363\t3/24/2015 60073\t10/30/2016 60752\t10/29/2015 61309\t9/27/2015 62116\t11/28/2015 62453\t11/14/2015 62727\t11/5/2015 63987\t1/8/2016 64556\t1/6/2016 65214\t1/1/2016 65698\t11/30/2015 66531\t8/9/2016 66620\t11/9/2015 68220\t9/28/2016 68650\t9/13/2016 69059\t9/22/2016 69210\t5/26/2016 69417\t9/7/2016 69787\t1/29/2017 70198\t11/30/2016 70590\t9/21/2016 70993\t12/6/2016 71368\t12/13/2016 71904\t3/30/2017 72550\t1/10/2017 72914\t3/29/2017 73285\t7/21/2017 73824\t4/5/2017 74175\t5/3/2017 75314\t5/11/2017 75728\t7/3/2017 76171\t7/7/2017 76624\t8/4/2017 77162\t8/10/2017 77576\t10/8/2017 77742\t10/2/2017 78128\t9/30/2017 78139\t9/22/2017 79481\t1/23/2018", "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.", "product_quantity": "1599 kits", "distribution_pattern": "Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.", "openfda": { "k_number": [ "K892808", "K914076", "K100702", "K973466", "K990656", "K021585", "K943288", "K961843", "K904965", "K072072", "K142076", "K132307", "K896674", "K093009", "K122875", "K854922", "K131893", "K974084", "K083066", "K140461", "K024132", "K060802", "K102758", "K974433", "K860739", "K781887", "K132747", "K944855", "K030906", "K891756", "K132551", "K042395", "K040015", "K090378", "K101537", "K071698", "K873786", "K820681", "K120392", "K140460", "K002463", "K982063", "K891757", "K070442", "K142984", "K900211", "K902864", "K000639", "K771865", "K080857", "K040735", "K011693", "K140812", "K963682", "K901830", "K965130", "K093010", "K140930", "K063333", "K061317", "K922836", "K984611", "K083323", "K993242", "K954169", "K992090", "K981081", "K915285", "K991527", "K042382", "K010716", "K031979", "K780666", "K031068" ], "registration_number": [ "3023808059", "3031700059", "2031963", "3011644607", "3025628903", "3009061550", "3042992004", "9710585", "9617655", "3006223081", "3000286616", "1000122786", "3003574554", "3007591382", "3030516433", "3007238566", "3027847726", "3012165496", "1066635", "3009028104", "3012092534", "3029970239", "1017294", "9612030", "3030558088", "3042991836", "3012272052", "1423537", "1225473", "3009542956", "1836161", "3002821232", "3031563141", "3015468226", "1043572", "3006437518", "1066270", "9710055", "9680506", "9710098", "8010153", "3021839632", "3015223105", "3005698350", "3029936435", "3007682310", "3026390991", "3020703842", "3015131225", "3010726901", "3009129579", "3010041511", "3011580044", "3011574775", "3035641086", "3011137372", "9611503", "3011910987", "3044829820", "1054713", "3002532594", "9681407", "3033527731", "1921846", "3007143268", "1825014", "3042970964", "3017970309" ], "fei_number": [ "1000114111", "3003779679", "3023808059", "1000396729", "3005747797", "3031700059", "1000214453", "3011644607", "3002957101", "3025628903", "3009061550", "3002750084", "3042992004", "3006223081", "3001236905", "3000286616", "1000122786", "3002939620", "3003574554", "3007591382", "3030516433", "3007238566", "3002808335", "3027847726", "3012165496", "3009028104", "3029970239", "3003184737", "1017294", "3030558088", "3042991836", "3012272052", "1000125341", "3009542956", "3002975342", "3002821232", "3031563141", "3015468226", "1043572", "3006437518", "3002465150", "3001237319", "3015223105", "3005698350", "3029936435", "3026390991", "3020703842", "3015131225", "3010726901", "3009129579", "3010041511", "3011580044", "3011574775", "1000182014", "3035641086", "3000957797", "3002806934", "3011910987", "3044829820", "3025504317", "3006125657", "3002532594", "3033527731", "1921846", "3007143268", "1825014", "3042970964", "3017970309" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }