{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104676", "product_res_number": "Z-0260-2012", "event_date_initiated": "2009-01-02", "event_date_posted": "2011-11-19", "recall_status": "Terminated", "event_date_terminated": "2011-12-13", "res_event_number": "60173", "product_code": "GAM", "k_numbers": [ "K002190" ], "product_description": "Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. \nThe product is a Violet, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 Metric), NFS-2 Needle (Product code 398A-Polyglycolic Acid) or size 2/0 (3.0 Metric) NFS-1 Needle. (Product code 453A-Polyglycolic Acid).\n\nProduct is labeled in part: \"***NFS-1***CUTTING***Coated POLYGLYCOLIC ACID Violet (PGA) Braided Absorbable Suture STERILE***Manufacturer CP Medical***\".\n\nIntended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.", "code_info": "398A and 453A", "firm_fei_number": "3002609049", "recalling_firm": "C P Medical Inc.", "address_1": "803 NE 25th Avenue", "city": "Portland", "state": "OR", "postal_code": "97232-2304", "additional_info_contact": "Barbara Keller Horton\n503-232-1555", "reason_for_recall": "The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.", "root_cause_description": "Nonconforming Material/Component", "action": "CP Medical, Inc. sent a \"RECALL NOTICE\" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall.", "product_quantity": "13632 sutures", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K060801", "K010672", "K980704", "K052437", "K180625", "K013671", "K150717", "K972566", "K181652", "K221527", "K091087", "K930588", "K252743", "K050845", "K120556", "K111442", "K173779", "K173043", "K093408", "K963253", "K042288", "K974299", "K200392", "K953869", "K962480", "K102592", "K141778", "K965162", "K033762", "K033746", "K013177", "K032586", "K041806", "K051415", "K142061", "K944937", "K930772", "K033115", "K031286", "K021767", "K060828", "K945285", "K232372", "K961997", "K040282", "K142822", "K081003", "K142810", "K062366", "K072644", "K990951", "K970317", "K073493", "K253852", "K080412", "K930746", "K161726", "K171494", "K000037", "K011375", "K072028", "K252820", "K141625", "K951520", "K143584", "K990432", "K944110", "K153611", "K151200", "K002190", "K173874", 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"3011803381", "3003828812", "3015489699", "3018094310", "1221601", "3015542154", "3013188547", "3017196117", "1054241", "3004944585", "3009380063", "2648623", "3013403214", "2030624", "3006680097", "1531174", "9681572", "2528981", "2320762", "1000274611", "3013557562", "3007791573", "3008879776", "3018052045", "3045857207", "1064584", "1720929", "2245304", "3004111573", "3014461810", "3043225236", "3011683674", "3014273254", "3004192065", "1721676", "1221934", "2521877", "3003639970", "3012101664", "3008912461", "1061124", "2650143", "3015207155", "3029901632", "1423662", "1219930", "3003595343", "3005953126", "2125050", "3010452421", "3010131137", "2648650", "3038718579", "3014592276", "3044819802", "3016904853", "9616088", "3045855232", "3003418325", "3007006186", "1058584", "3001124136", "3008868758", "1423537", "3012421607", "3006638824", "3012502601", "3013176080", "3019924", "3027448274", "3011689956", "1043214", "3002692886", "1037089", "3002294946", "3010041511", "3010860245", "3030446844", "3015453963", "3018064853", "1066741", "3003300673", "3024021261", "3014479313", "3010419931", "3006562124", "2183744", "3003267729", "2246552", "2020601", "3010692967", "3004117249", "3004903580", "2183301", "1018470", "3013187142", "3032543753", "1825034", "3004215117", "3010864832", "3020983460", "3014279513", "2210968", "3014579161", "3009968482", "3007205024", "3014276972", "3043226252", "9612501", "3014272734", "1055236", "1319660", "3011137372", "1320468", "1036836", "3015330532", "3004431266", "3006425876", "3005941719", "9611459", "3013548553", "3013298431", "3017102971", "3007009755", "3014615644", "1614993", "3006981798", "3007791599", "1319639", "3011276344", "3045857302", "1064514", "3005972890", "9680794", "9617547", "3004365956", "3011085362", "3035366890", "3008114965", "3000268902", "9710098", "3004060107" ], "fei_number": [ "1000219637", "3030733800", "3004845555", "3013644499", "3012494290", "3011803381", "3003828812", "3015489699", "3018094310", 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"3010860245", "3030446844", "3015453963", "1000136478", "3018064853", "3000206455", "3003300673", "1000512168", "3024021261", "3010419931", "3014479313", "3006562124", "2183744", "3003267729", "2246552", "2020601", "3010692967", "3004117249", "3004903580", "2183301", "1018470", "3013187142", "3032543753", "1825034", "3004215117", "3004161528", "3020983460", "3014279513", "2210968", "3014579161", "3009968482", "3007205024", "3003272809", "3014276972", "3043226252", "3014272734", "1000112968", "1036836", "3015330532", "3004431266", "2648209", "3010862763", "3006425876", "3013548553", "3013298431", "3017102971", "3007009755", "3014615644", "1614993", "3002807111", "3006981798", "3007791599", "3011276344", "3003737899", "3045857302", "3005972890", "3004365956", "3011085362", "3035366890", "3008114965", "3000268902", "3004060107", "3000206435" ], "device_name": "Suture, Absorbable, Synthetic, Polyglycolic Acid", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4493", "device_class": "2" } } ] }