{ "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": "149709", "product_res_number": "Z-0180-2017", "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": "Endoscopy Pack, Kit number PSS1646\n\nconvenience custom kits used for general surgery in hospital operating room", "code_info": "Lot numbers/Expiration dates:  59053\t3/28/2015 77459\t9/11/2015 65230\t10/26/2015 60259\t10/27/2015 61170\t11/14/2015 66914\t11/26/2015 64387\t1/11/2016 63883\t1/25/2016 57221\t6/19/2016 57956\t7/20/2016 77460\t7/30/2016 69800\t9/6/2016 70560\t12/3/2016 72104\t1/1/2017 72585\t4/19/2017", "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": "304 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" } } ] }