{ "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": "130358", "product_res_number": "Z-0140-2015", "event_date_initiated": "2014-09-22", "event_date_posted": "2014-10-27", "recall_status": "Terminated", "event_date_terminated": "2015-02-17", "res_event_number": "69373", "product_code": "NEW", "product_description": "Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.", "code_info": "Product Lot Number (s) Code  L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.", "firm_fei_number": "3002609049", "recalling_firm": "C P Medical, Inc.", "address_1": "803 NE 25th Ave", "city": "Portland", "state": "OR", "postal_code": "97232-2304", "additional_info_contact": "Customer Service\n503-232-1555", "reason_for_recall": "CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.", "root_cause_description": "Nonconforming Material/Component", "action": "CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. \r\n\r\nCustomers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. \r\n\r\nCustomers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.", "product_quantity": "74 boxes /12 sutures per box; plus an additional 13 sutures", "distribution_pattern": "US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA", "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" } } ] }