{ "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": "149767", "product_res_number": "Z-0204-2017", "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": "Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073.\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot codes/Expiration dates:  65013\t3/1/2014 58261\t3/20/2014 58964\t3/27/2014 61857\t4/10/2014 60968\t4/20/2014 57095\t4/25/2014 59002\t5/2/2014 60388\t5/5/2014 60299\t6/30/2014 62798\t8/21/2014 62654\t10/25/2014 64447\t12/5/2014 63072\t12/9/2014 64328\t12/13/2014 64679\t12/18/2014 63368\t12/20/2014 63799\t1/13/2015 66644\t2/2/2015 66509\t2/14/2015 65777\t2/25/2015 65573\t2/25/2015 65718\t2/28/2015 65875\t3/6/2015 65572\t3/15/2015 59027\t3/26/2015 58692\t4/5/2015 68613\t4/12/2015 67175\t4/14/2015 57249\t4/20/2015 68069\t4/28/2015 59297\t7/3/2015 59538\t7/4/2015 59157\t7/13/2015 59846\t8/2/2015 60663\t8/4/2015 60131\t8/5/2015 60113\t8/6/2015 60132\t8/6/2015 70171\t8/13/2015 61311\t8/18/2015 61435\t8/20/2015 59514\t8/24/2015 59845\t8/31/2015 60605\t9/7/2015 60754\t9/7/2015 61006\t9/7/2015 60722\t9/11/2015 61164\t9/14/2015 60662\t9/20/2015 61479\t9/21/2015 68892\t9/29/2015 61310\t10/16/2015 65295\t11/2/2015 71133\t11/2/2015 62199\t11/5/2015 62600\t11/5/2015 62349\t11/6/2015 61601\t11/6/2015 64476\t11/6/2015 66318\t11/6/2015 61521\t11/7/2015 66319\t11/8/2015 65296\t11/10/2015 64850\t11/11/2015 64477\t11/11/2015 62200\t11/13/2015 62943\t11/13/2015 70754\t11/13/2015 62903\t11/14/2015 63199\t11/15/2015 61602\t11/23/2015 61642\t11/26/2015 62425\t11/27/2015 62546\t11/27/2015 66795\t11/27/2015 61603\t11/29/2015 65598\t11/30/2015 65700\t11/30/2015 72347\t12/4/2015 72783\t12/15/2015 72804\t12/21/2015 65699\t12/23/2015 65294\t12/26/2015 65195\t12/27/2015 64632\t1/2/2016 73047\t1/6/2016 64291\t1/7/2016 64349\t1/8/2016 63430\t1/9/2016 65019\t1/12/2016 64475\t1/16/2016 63200\t1/18/2016 63711\t1/22/2016 63948\t1/25/2016 64042\t1/30/2016 63984\t1/30/2016 67589\t2/5/2016 69258\t2/5/2016 69459\t2/5/2016 71210\t2/11/2016 66794\t2/14/2016 68862\t2/14/2016 69603\t2/20/2016 69604\t2/20/2016 67588\t2/24/2016 74530\t2/25/2016 73860\t3/6/2016 74555\t3/10/2016 68572\t3/13/2016 68863\t3/22/2016 69062\t3/26/2016 66552\t4/4/2016 70511\t4/6/2016 71878\t4/8/2016 70512\t4/10/2016 70267\t4/14/2016 70268\t4/16/2016 74731\t4/18/2016 69605\t4/20/2016 69866\t4/23/2016 70510\t4/24/2016 73286\t4/24/2016 74443\t4/25/2016 77115\t5/10/2016 75128\t5/17/2016 75800\t5/22/2016 56502\t5/23/2016 56722\t5/30/2016 57013\t6/7/2016 56723\t6/12/2016 57469\t6/18/2016 57573\t6/27/2016 71877\t7/2/2016 71435\t7/4/2016 66796\t7/5/2016 57790\t7/8/2016 57774\t7/9/2016 71073\t7/13/2016 66551\t7/14/2016 71879\t7/15/2016 58288\t7/16/2016 57645\t7/17/2016 77366\t7/17/2016 57945\t7/18/2016 71437\t7/18/2016 71982\t7/22/2016 69061\t7/26/2016 71268\t7/26/2016 71981\t7/29/2016 78379\t7/29/2016 77328\t7/30/2016 78043\t7/30/2016 78160\t7/30/2016 58451\t7/31/2016 58067\t8/2/2016 71436\t8/5/2016 67206\t8/11/2016 58275\t8/14/2016 58587\t8/30/2016 78339\t8/31/2016 75047\t9/2/2016 79834\t10/12/2016 81141\t10/31/2016 78837\t11/5/2016 80914\t11/6/2016 60593\t11/26/2016 77334\t7/20/2017 76451\t7/22/2017 77342\t10/1/2017", "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": "8132 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" } } ] }