{ "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": "141625", "product_res_number": "Z-0355-2016", "event_date_initiated": "2015-10-27", "event_date_posted": "2015-12-01", "recall_status": "Terminated", "event_date_terminated": "2016-04-01", "res_event_number": "72596", "product_code": "DRE", "k_numbers": [ "K810859" ], "product_description": "U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387.\n\nAll needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.", "code_info": "Lot 9184-A", "firm_fei_number": "3020778", "recalling_firm": "Procedure Products, Inc.", "address_1": "1801 W Fourth Plain Blvd", "city": "Vancouver", "state": "WA", "postal_code": "98660-1310", "additional_info_contact": "Doug Rowley\n360-693-1832", "reason_for_recall": "The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle", "root_cause_description": "Nonconforming Material/Component", "action": "The firm sent the Urgent Medical Device Recall letter to their consignees via email on 10/27/15.\n\nCustomers with questions can call Doug Rowley at 360-693-1832 or send email to doug@procedureproducts.com", "product_quantity": "1100 pieces", "distribution_pattern": "Distributed in the states of MT and NY.", "openfda": { "k_number": [ "K133631", "K050962", "K801113", "K172487", "K901815", "K151076", "K232609", "K141148", "K810859", "K120349", "K912050", "K253616", "K802327", "K092378", "K103421", "K974640", "K894330", "K052557", "K200379", "K000737", "K974617", "K960917", "K860161", "K140047", "K850337", "K831190", "K023507", "K182914", "K150932", "K251325", "K081940", "K210734", "K862288", "K170616", "K813125", "K150360", "K192195", "K093554", "K945586", "K905416", "K870413", "K780126", "K010055", "K760403", "K914555", "K141070", "K261310", "K151877", "K132713", "K183036", "K822595", "K840022", "K800462", "K813461", "K872724", "K874738", "K875327", "K141131", "K871148", "K070749", "K123842", "K142546", "K161333", "K201288", "K071330", "K970392", "K161336", "K190175", "K162389", "K840671", "K913027", "K091584", "K902469", "K841995", "K030260", "K142301", "K904476", "K212784", "K130791", "K123445", "K082075", "K031691", "K882238", "K242229", "K840017", "K162181", "K233647", "K192283", "K061000", "K223472", "K833965", "K241720", "K896096", "K070159", "K182064", "K843261", "K062554", "K963388", "K881073", "K970470", "K012256", "K842113", "K211679", "K073035", "K980282" ], "registration_number": [ "", "2518902", "3019807891", "1644312", "9681477", "1282497", "3007146453", "3012453745", "2032521", "3005580113", "9616099", "1000393132", "1319639", "1054241", "2528981", "1721504", "3004784537", "3003915875", "1722746", "3007695959", "3011642792", "3014656749", "3006082230", "9616683", "3005941719", "3009211636", "1721676", "3033589330", "1000121056", "1055236", "3005334138", "3031571797", "3011623145", "1319211", "3007882731", "3004111573", "1643817", "9612126", "3008423561", "3036802499", "3038188187", "3011468686", "1016427", "9611665", "2182208", "1043214", "2124215", "2246552", "2648727", "3019751610", "1123137", "3011657089", "3020778", "1820334", "3015225571", "3030574705", "3030446844", "3030714660", "2030624", "1828424", "2183744", "9680841", "1928237", "8010762", "2032228", "3006283319", "3003637635", "3007284006", "3018565086", "3030447506", "3025341484", "2011171", "3012536737", "1721686", "2648045", "2522007", "2527072", "9610139", "1625425", "3027260597", "8043892", "3009888344", "3010665433", "9610849", "1724474", "3002807314", "3006950086", "1718850", "3010273872", "1000523114", "9616662", "1018233", "2953359", "3015309643", "3032916632", "2029275", "3013666336", "3000126629", "1649395" ], "fei_number": [ "", "2518902", "3019807891", "1282497", "3007146453", "3012453745", "3009649876", "3005580113", "1000393132", "2528981", "1721504", "3004784537", "1000117748", "3002808050", "3003915875", "3003574398", "3003094851", "3007695959", "1000138054", "3011642792", "3002807439", "3002807111", "3014656749", "3006082230", "1000306431", "3000206435", "3009211636", "1721676", "3033589330", "3000335778", "3002807095", "1000121056", "3005334138", "3031571797", "3011623145", "1319211", "3007882731", "3004111573", "1643817", "3008423561", "3036802499", "3038188187", "3011468686", "1016427", "3002807548", "3003528016", "2182208", "1043214", "1000112877", "2124215", "2246552", "1000112968", "2648727", "3019751610", "3011657089", "3020778", "1820334", "3015225571", "3030574705", "3004970277", "3030446844", "3030714660", "1000306216", "1828424", "3000215205", "2183744", "1928237", "3006283319", "3003637635", "3007284006", "3018565086", "3030447506", "3025341484", "2011171", "3012536737", "3003166981", "1721686", "2648045", "3002806500", "1000123180", "2522007", "2527072", "1625425", "3027260597", "3009888344", "3010665433", "3002807314", "3006950086", "1718850", "3002807391", "3010273872", "1000523114", "3000718472", "1018233", "3015309643", "3032916632", "3013666336", "3005426550", "3000126629" ], "device_name": "Dilator, Vessel, For Percutaneous Catheterization", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1310", "device_class": "2" } } ] }