{ "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": "149615", "product_res_number": "Z-0147-2017", "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 Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. \n\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot Numbers/Expiration Dates:  56104\t4/5/2015 56836\t6/19/2016 57228\t5/22/2016 57473\t6/26/2016 58063\t8/6/2016 58068\t7/11/2016 58357\t7/31/2016 58588\t4/10/2015 59298\t3/11/2015 59847\t9/13/2015 60274\t11/4/2015 60353\t7/18/2015 60354\t7/22/2015 60649\t10/28/2015 60797\t11/5/2015 61071\t10/3/2015 61873\t11/28/2015 62203\t11/7/2015 62456\t11/28/2015 62945\t11/2/2015 63065\t9/3/2015 63204\t11/11/2015 63665\t1/29/2016 64166\t1/6/2016 64470\t1/13/2016 64559\t1/29/2016 64750\t1/18/2016 64819\t10/11/2015 64976\t1/14/2016 65020\t6/27/2017 65048\t11/1/2015 65116\t1/17/2016 65411\t11/1/2015 65442\t11/15/2015 65737\t2/15/2016 65804\t2/25/2015 65879\t12/22/2015 66321\t11/12/2015 66395\t6/27/2015 66696\t11/4/2015 67207\t11/16/2015 67521\t8/21/2015 67551\t7/23/2016 67694\t5/2/2015 67700\t7/26/2016 67701\t7/4/2016 67810\t8/10/2016 67966\t7/15/2016 68145\t8/28/2016 68387\t7/6/2016 68410\t9/21/2016 68413\t9/25/2015 68710\t9/13/2016 68711\t9/22/2016 68721\t9/18/2016 68822\t9/5/2016 68857\t2/21/2015 69056\t11/26/2017 69067\t9/20/2016 69191\t9/16/2016 69343\t9/5/2016 69344\t9/11/2016 69345\t9/14/2016 69549\t9/20/2016 69646\t12/24/2016 69893\t3/29/2017 70157\t9/12/2016 70176\t12/12/2015 70966\t7/11/2016 70970\t10/10/2016 71156\t12/27/2016 71450\t2/13/2015 71634\t1/5/2017 71634\t1/5/2017 71788\t10/20/2016 71945\t1/3/2017 71955\t2/7/2015 71987\t1/21/2017 72112\t3/24/2017 72306\t1/7/2017 72490\t3/21/2017 72616\t3/23/2017 72640\t3/12/2017 72978\t3/1/2017 72978\t3/1/2017 73191\t8/21/2016 73203\t3/8/2017 73204\t4/20/2017 73428\t4/4/2017 73645\t1/22/2017 73646\t4/5/2017 73826\t7/27/2017 73933\t4/13/2017 73933\t4/13/2017 73934\t5/3/2017 74061\t1/16/2017 74442\t4/20/2017 74460\t5/9/2017 75094\t5/4/2017 75255\t6/21/2017 75455\t6/25/2016 75646\t7/16/2017 75745\t6/27/2016 75830\t7/9/2017 75902\t7/11/2017 76026\t7/2/2017 76034\t7/23/2017 76083\t4/23/2017 76141\t7/9/2017 76142\t4/23/2017 76152\t7/30/2016 76161\t8/30/2017 76236\t7/15/2016 76662\t10/25/2017 76680\t8/29/2017 76917\t8/5/2017 76948\t8/30/2017 77315\t10/1/2017 77434\t8/14/2017 77518\t9/27/2017 77771\t10/9/2017 77845\t8/23/2017 78027\t9/2/2017 78325\t8/26/2017 78337\t11/9/2017 78641\t9/2/2017 78743\t9/19/2017 78879\t11/2/2017 78980\t1/6/2018 79248\t9/10/2017 79315\t1/17/2018 79497\t1/2/2018 79657\t2/2/2018 80442\t2/26/2018 80608\t1/19/2018 80916\t1/9/2018", "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": "6381 kits", "distribution_pattern": "Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.", "openfda": { "k_number": [ "K140812", "K860739", "K040735", "K101537", "K922836", "K961843", "K071698", "K002463", "K132551", "K142984", "K992090", "K140930", "K142076", "K060802", "K873786", "K982063", "K042382", "K131893", "K990656", "K024132", "K902864", "K944855", "K943288", "K901830", "K896674", "K984611", "K031979", "K090378", "K781887", "K132307", "K974084", "K854922", "K040015", "K963682", "K981081", "K900211", "K031068", "K000639", "K010716", "K083323", "K140461", "K820681", "K771865", "K102758", "K140460", "K122875", "K965130", "K993242", "K100702", "K093010", "K083066", "K915285", "K132747", "K072072", "K011693", "K070442", "K021585", "K891757", "K914076", "K891756", "K042395", "K080857", "K954169", "K892808", "K974433", "K904965", "K063333", "K093009", "K030906", "K991527", "K973466", "K780666", "K061317", "K120392" ], "registration_number": [ "3006437518", "1423537", "1825014", "3012092534", "3044829820", "3026390991", "3015131225", "3005698350", "9681407", "1225473", "8010153", "9710055", "3042970964", "3011137372", "1921846", "3030558088", "3025628903", "3007682310", "3020703842", "1043572", "3011910987", "3035641086", "3006223081", "2031963", "3010726901", "3002821232", "3029970239", "3042992004", "3010041511", "9680506", "3031700059", "1066270", "3007591382", "3031563141", "3011580044", "3007143268", "3009129579", "3017970309", "3027847726", "3011574775", "1066635", "3012272052", "1054713", "9612030", "3042991836", "3009028104", "3015468226", "3011644607", "3009061550", "9617655", "1017294", "3029936435", "3002532594", "3033527731", "3021839632", "9710585", "1000122786", "3003574554", "3000286616", "3009542956", "1836161", "3007238566", "3023808059", "9710098", "3015223105", "9611503", "3012165496", "3030516433" ], "fei_number": [ "1000182014", "3006437518", "1825014", "1000396729", "3025504317", "3002750084", "3044829820", "3026390991", "3015131225", "3005698350", "3002808335", "3001237319", "3030516433", "3001236905", "3042970964", "1921846", "3030558088", "3025628903", "3020703842", "1000214453", "1043572", "3011910987", "3035641086", "3000957797", "3006223081", "3010726901", "3002821232", "3029970239", "3003184737", "3042992004", "3010041511", "3006125657", "3031700059", "3007591382", "3031563141", "3002465150", "3011580044", "3007143268", "3009129579", "3017970309", "3027847726", "3011574775", "3042991836", "3012272052", "3009028104", "3002975342", "3015468226", "3011644607", "3009061550", "1000125341", "3005747797", "1017294", "3002806934", "3029936435", "3002532594", "3033527731", "1000122786", "3003574554", "3000286616", "3009542956", "3007238566", "3023808059", "3015223105", "1000114111", "3003779679", "3012165496", "3002957101", "3002939620" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }