{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "51929", "product_res_number": "Z-0808-2007", "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": "GAW", "k_numbers": [ "K001185" ], "product_description": "Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap 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) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile Manufactured by: CP Medical Portland, OR USA' . Side of box has an adhesive sticker label which includes: 'Vet Use Only'.\n\nPacket Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO Manufacturer: CP Medical Portland, OR USA' .\n\nProduct is also distributed under two private labels, Webster Veterinary and Butler. \nWebster Veterinary Box Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. \n\nWebster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only Distributed by: Webster Veterinary Supply, Inc. 07-836-4643(8665P) 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'.\n\nButler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. \n\nButler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.", "code_info": "CP Medical Product label is coded 8665P. Lot number J0629930-1 expiration 2011-09.  Private distributed label for Webster Veterinary is coded 07-836-4643(8665P). Lot number J0629930-1 expiration 2011-09.  Private distributed label for Butler is coded 032002. Lot number J0629930-1 expiration 2011-09.", "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": "1332 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": [ "K994313", "K961389", "K980703", "K931917", "K002435", "K180321", "K143582", "K050947", "K903643", "K002999", "K012865", "K945701", "K052701", "K233355", "K010990", "K993997", "K093112", "K010909", "K001703", "K141206", "K050247", "K130078", "K930587", "K060414", "K070243", "K100593", "K000537", "K953609", "K062125", "K193530", "K052962", "K043330", "K160529", "K162617", "K983108", "K992405", "K001185", "K042856", "K061700", "K911905", "K903176", "K171039", "K001625", "K043591", "K920437", "K113800", "K926588", "K173644", "K954808", "K904906", "K230746", "K133356", "K050548", "K221280", "K142639", "K961168", "K020940", "K131224", "K922630", "K911189", "K113763", "K171005", "K020265", "K042283", "K053482", "K960209", "K052373", "K192953", "K133890", "K253572", "K002557", "K041511", "K173747", "K191299", "K151112", "K902872", "K041593", "K113494", "K903584", "K211178", "K931614", "K914588", "K021834", "K013683", "K930941" ], "pma_number": [ "P820083", "P890002" ], "registration_number": [ "3013403214", "2210968", "3013298431", "3012026312", "1531174", "3035387162", "3014592276", "9710098", "9611459", "3016678045", "3008912461", "3017196117", "2648623", "2650143", "3004215117", "2183301", "3015330532", "3044819802", "3009513193", "3010864832", "3003910212", "3029901632", "9612501", "3014615644", "3018094310", "2031768", "3018052045", "3045857302", "3014772181", "3043226252", "3010692967", "3004111573", "1017294", "3004365956", "3017102971", "3005953126", "1000274611", "3014461810", "9616088", "3025431509", "3003595343", "1018470", "3010041511", "1221601", "3003639970", "1219930", "3010452421", "2648650", "3030733800", "3013517171", "3011276344", "3012494290", "3012421607", "3004117249", "1320468", "3007205024", "1423537", "1043214", "1721676", "3010131137", "3004192065", "3013354263", "3038718579", "3013187142", "1066741", "3045855232", "3008483449", "1061124", "1062741", "3013557562", "3004944585", "3032543753", "3012502601", "3006638824", "3029754081", "3006562124", "3013188547", "1055236", "3019807891", "2032098", "1064584", "9617547", "3016904853", "3016426842", "3012101664", "3003267729", "3006981798", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "2246552", "1064017", "2183744", "1319639", "3009142291", "3004060107", "3030446844", "1064514", "2030624", "1054241", "9680794", "3011137372", "2320762", "3006425876", "3004903580", "3009968482", "2528981", "3014579161", "3020983460", "3014279513" ], "fei_number": [ "3013403214", "1000138054", "2210968", "3002902735", "3005747797", "3002957101", "3001236905", "3013298431", "3012026312", "3035387162", "3014592276", "3003040625", "2648209", "3016678045", "3008912461", "3000206435", "3017196117", "2648623", "3004215117", "2183301", "3000206455", "3015330532", "3044819802", "3009513193", "3003910212", "3029901632", "3000302153", "3014615644", "3018094310", "3003063934", "3018052045", "3045857302", "3014772181", "3043226252", "3010692967", "3004111573", "1017294", "3004161528", "3004365956", "3017102971", "3005953126", "1000274611", "3014461810", "3025431509", "3003595343", "1018470", "3010041511", "3003058448", "1221601", "3003639970", "1219930", "3010452421", "2648650", "3030733800", "3003495548", "3002690289", "3013517171", "3002993297", "3011276344", "3012494290", "3012421607", "3002807993", "3004117249", "3007205024", "1043214", "1000112968", "1721676", "3010131137", "3004192065", "3013354263", "3038718579", "3013187142", "1000512168", "3003737899", "3045855232", "3008483449", "3003005156", "3013557562", "3004944585", "3032543753", "3012502601", "3010862763", "3006638824", "3029754081", "3006562124", "3013188547", "3019807891", "1000112877", "3000190635", "3003272809", "3016904853", "3016426842", "3012101664", "3003267729", "3006981798", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "2246552", "2183744", "3009142291", "3004060107", "3030446844", "3006425876", "3004903580", "3009968482", "2528981", "3014579161", "3020983460", "3014279513" ], "device_name": "Suture, Nonabsorbable, Synthetic, Polypropylene", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5010", "device_class": "2" } } ] }