{ "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": "149878", "product_res_number": "Z-0269-2017", "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": "Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B.\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot Number/ Expiration Date:  59007\t8/27/2013 57610\t8/31/2013 60128\t12/15/2013 62099\t12/21/2013 61297\t2/9/2014 62189\t2/12/2014 57522\t4/30/2014 60028\t5/12/2014 60303\t5/19/2014 61416\t8/17/2014 63836\t9/7/2014 66799\t9/19/2014 61924\t12/3/2014 63333\t12/8/2014 65167\t12/31/2014 67369\t2/4/2015 68073\t4/17/2015 70983\t9/6/2015 70169\t9/21/2015 71061\t10/10/2015 65331\t11/5/2015 62082\t11/7/2015 66580\t11/20/2015 64544\t1/29/2016 68947\t2/19/2016 74854\t3/23/2016 75534\t4/25/2016 69610\t5/7/2016 71352\t6/17/2016 66677\t7/5/2016 67866\t7/6/2016 67702\t7/30/2016 77629\t7/30/2016 78550\t7/30/2016 68712\t9/13/2016 68215\t9/17/2016 79701\t10/11/2016 70494\t10/17/2016 75648\t12/1/2016 71381\t12/12/2016 76128\t1/22/2017 72479\t3/15/2017 72951\t3/24/2017 73131\t4/15/2017 74758\t5/5/2017 73849\t5/7/2017 73192\t5/30/2017 76672\t7/17/2017 80956\t8/8/2017 78024\t8/23/2017 77684\t10/24/2017 79660\t1/9/2018 78944\t1/16/2018", "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": "1124 kits", "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" } } ] }