{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "52130", "product_res_number": "Z-0809-2007", "event_date_initiated": "2007-04-03", "event_date_posted": "2007-05-24", "recall_status": "Terminated", "event_date_terminated": "2008-08-01", "res_event_number": "37756", "product_code": "GAM", "k_numbers": [ "K013274" ], "product_description": "Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. \n\nBox Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm 3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm) One Dozen Sterile Synthetic Absorbable Suture '.\n\nPacket Label includes: '3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO Manufacturer: CP Medical Portland, OR USA' .\n\nProduct is also distributed under three private labels, Webster Veterinary, Butler, and Phoenix Pharmaceutical, Inc. \nWebster Veterinary Box Label includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01 Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. \n\nWebster Veterinary Packet Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only Distributed by: Webster Veterinary Supply, Inc. CUTTING NFS-2 3/8 19mm 26-SM398A-01'.\n\nButler Box label includes: 'Butler 3/0 (2.0 metric) MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. \n\nButler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm) 029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.\n\nPhoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'.\n\nPhoenix Pharmaceutical Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable Suture Veterinary Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'.", "code_info": "CP Medical Product label is coded M398A. Lot number 070122-03 expiration 2010-12. Private distributed label for Webster Veterinary is coded 07-836-4288(M398A). Lot number 070122-03 expiration 2010-12. Private distributed label for Butler is coded 029254. Lot number 070122-03 expiration 2010-12. Private distributed label for Phoenix Pharmaceutical is coded 0398. Lot number 070122-03 expiration 2010-12.", "firm_fei_number": "3002609049", "recalling_firm": "C P Medical", "address_1": "803 Ne 25th Ave", "city": "Portland", "state": "OR", "postal_code": "97232", "additional_info_contact": "Madalyn C. Duncan\n503-445-1619", "reason_for_recall": "Potential for sterility of product to be compromised. Suture package seals incomplete or missing.", "root_cause_description": "Other", "action": "On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.\n\nOn 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.", "product_quantity": "13,596 suture packets", "distribution_pattern": "Firm distributes products to human and veterinary medical device distribution centers worldwide. \n\nPolybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa.\n\nPolypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution.\n\nPolydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution.", "openfda": { "k_number": [ "K080412", "K021767", "K980610", "K032698", "K091087", "K963253", "K202950", "K123836", "K072859", 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"K073493", "K023710", "K991191", "K181652", "K142810", "K930772", "K965162", "K180625", "K072229", "K060828", "K051415", "K211792", "K142822", "K160564", "K980704", "K930588", "K970317", "K962480", "K201996", "K951352", "K173043", "K002639", "K964345", "K181320", "K994001", "K970863", "K010672", "K002190", "K013671", "K974299", "K946271", "K081003", "K161726", "K253530", "K915835", "K172659", "K944110", "K041806", "K140227", "K140039", "K123940", "K153611", "K031286", "K072028", "K033115", "K200392", "K170166", "K022715", "K123409" ], "pma_number": [ "N18387", "N16881", "P840051" ], "registration_number": [ "3014461810", "3003828812", "3013403214", "3030446844", "3003595343", "3001124136", "2648623", "3006981798", "3007205024", "3004215117", "3035366890", "3011803381", "3012421607", "2650143", "1037089", "1018470", "3019924", "3010860245", "3043226252", "1825034", "3013557562", "1000274611", "3011276344", "3009968482", "3003418325", "1221934", "3009380063", "3010452421", "1064514", "3044819802", "1064584", "3010692967", "3014615644", "3005953126", "3020983460", "3012502601", "3045855232", "3003267729", "9710098", "9680794", "2210968", "3032543753", "1423662", "3007791599", "3004431266", "9611459", "1036836", "1720929", "2245304", "1319660", "3013188547", "3010419931", "3043225236", "3030733800", "1061124", "1531174", "3004903580", "3045857302", "9681572", "3008879776", "3017102971", "3015453963", "3013298431", "2528981", "3006680097", "3024021261", "3013644499", "3013187142", "3006638824", "3004111573", "3005941719", "3002692886", "3012494290", "3015489699", "2246552", "3018052045", "3002294946", "3018094310", "3011683674", "3007006186", "3014276972", "3005972890", "3010041511", "3013548553", "3016904853", "2020601", "3013176080", "1219930", "3027448274", "3004845555", "3014272734", "3008114965", "3011137372", "3006562124", "1043214", "3004192065", "3007009755", "1066741", "3045857207", "1319639", "3011689956", "2648650", "3010864832", "3004060107", "3038718579", 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"3020983460", "3003263857", "3012502601", "3045855232", "3003267729", "2210968", "3032543753", "3004161528", "3007791599", "3002957101", "3002993297", "3004431266", "1036836", "1720929", "2245304", "1000136478", "3013188547", "1000138054", "3010419931", "3043225236", "3030733800", "3000215273", "3004903580", "3045857302", "3008879776", "3017102971", "3015453963", "3013298431", "2528981", "3006680097", "3024021261", "3013644499", "3013187142", "1000112877", "3006638824", "3004111573", "1000219637", "3002692886", "3012494290", "3015489699", "2246552", "3018052045", "3003737899", "3002294946", "3018094310", "3011683674", "3007006186", "3014276972", "3005972890", "3010041511", "3013548553", "3016904853", "2020601", "3013176080", "1219930", "3027448274", "3004845555", "3014272734", "3008114965", "1000112968", "3006562124", "1043214", "3004192065", "3010862763", "3003005156", "3007009755", "3001236905", "3045857207", "3011689956", "2648650", "3004060107", "3038718579", "3008868758", "3004944585", "1221601", "3000268902", "1000512168", "3011085362", "3018064853", "2183301", "3010131137", "3029901632", "3014592276", "3017196117", "3015207155", "3006425876", "3000206435", "1721676", "2521877", "3014273254", "3004117249", "3002807993", "3015542154", "3007791573", "2183744", "3012101664", "3002902735", "3005747797", "3014279513", "3014579161", "3014479313", "3000206455", "3003495548", "3015330532", "3004365956", "3008912461", "2125050", "2648209", "3003639970", "1614993", "3003300673", "3003040625" ], "device_name": "Suture, Absorbable, Synthetic, Polyglycolic Acid", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4493", "device_class": "2" } } ] }