{ "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": "119650", "product_res_number": "Z-0347-2014", "event_date_initiated": "2012-12-13", "event_date_posted": "2013-11-18", "recall_status": "Terminated", "event_date_terminated": "2013-11-21", "res_event_number": "65584", "product_code": "NEW", "k_numbers": [ "K100461" ], "product_description": "Polyglycolic-Lactic Acid Absorbable Surgical Suture\n\nLabel reads in part \"Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***\"\n\nPGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues", "code_info": "Lot 120716-01", "firm_fei_number": "3006981798", "recalling_firm": "Riverpoint Medical, LLC", "address_1": "825 NE 25th Ave", "city": "Portland", "state": "OR", "postal_code": "97232-2304", "additional_info_contact": "Doug Rowley\n503-517-8001", "reason_for_recall": "Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.", "root_cause_description": "Employee error", "action": "Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement.\nFor questions regarding this recall call 503-517-8001.", "product_quantity": "1932 pieces", "distribution_pattern": "US Distribution in the states of: AZ, FL, and TX.", "openfda": { "k_number": [ "K080680", "K232246", "K123668", "K073614", "K113004", "K081001", "K063680", "K190245", "K250107", "K240389", "K013274", "K123877", "K242835", "K042075", "K150670", "K220549", "K132268", "K022666", "K080918", "K210871", "K051609", "K252171", "K133420", "K041048", "K040004", "K043298", "K100461", "K082097", "K250977", "K192423", "K053380", "K031443", "K182873", "K243897", "K192144", "K160761", "K201139", "K120827", "K172602", "K071989", "K212380", "K252047", "K120284", "K162366", "K113744", "K242571", "K100780", "K143413", "K160705", "K190264", "K141776", "K181582", "K252644", "K042285", "K191361", "K030786", "K251414", "K031216", "K130191", "K150553", "K030212", "K261988", "K061037", "K080985", "K161737" ], "pma_number": [ "N18331" ], "registration_number": [ "", "3017936846", "3029901632", "3004845555", "1054241", "1320468", "3044819802", "2528981", "3006638824", "3017102971", "1614993", "3010864832", "3014527910", "3016560306", "3016010820", "1721676", "3045855232", "1055236", "3013529787", "3020983460", "2125050", "1221601", "3007895168", "3014615644", "3015812758", "3013557562", "3014461810", "3003828812", "1043214", "3002294946", "2246552", "3004944585", "3010041511", "3006981798", "3010131137", "3011689956", "3012502601", "2030624", "3013298431", "3006562124", "3004365956", "3013589761", "2183744", "3014273254", "3011137372", "3015138222", "9617547", "3005953126", "3007791599", "3003267729", "3008114965", "3012421607", "3010462274", "1000274611", "3013403214", "3006680097", "3038138322", "3014272734", "3023274465", "3008868758", "3012494290", "3015289316", "2648650", "3018052045", "3010692967", "3014579161", "3013354263", "2210968", "2650143", "3030733800", "3013376016", "3012438919", "3016244792", "3005972890", "3007205024", "1064584", "3003639970", "1018470", "3011555199", "3013187142", "3016445763", "3008912461", "1221934", "3043226252", "3004117249", "3016904853", "3027329031" ], "fei_number": [ "", "3017936846", "3029901632", "3004845555", "3044819802", "2528981", "3006638824", "3017102971", "1614993", "3014527910", "3016560306", "3000206435", "3016010820", "3003272809", "1721676", "2648209", "3045855232", "3013529787", "3020983460", "2125050", "1221601", "3007895168", "3014615644", "3015812758", "3013557562", "3014461810", "3003828812", "1043214", "1000112877", "3002294946", "2246552", "3004944585", "1000112968", "3010041511", "3006981798", "3010131137", "3011689956", "3012502601", "3013298431", "3000206455", "3006562124", "3004365956", "3013589761", "2183744", "3014273254", "3015138222", "3005953126", "3007791599", "3003267729", "3008114965", "3012421607", "3010462274", "1000274611", "3013403214", "3006680097", "3038138322", "3014272734", "3023274465", "3008868758", "3012494290", "3015289316", "2648650", "3018052045", "3010692967", "3014579161", "3013354263", "2210968", "3030733800", "3013376016", "3012438919", "3016244792", "3005972890", "3007205024", "3003639970", "3010862763", "1018470", "3011555199", "3013187142", "3016445763", "3008912461", "1221934", "3043226252", "3004117249", "3016904853", "3027329031", "3003063934", "3005747797" ], "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2" } } ] }