{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "51466", "product_res_number": "Z-0807-2007", "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": "GAT", "k_numbers": [ "K001172" ], "product_description": "Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER 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. \n\nProduct overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'.\n\nProduct box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' .\n\n\nProduct was distributed to single consignee, a distributor in South Africa.", "code_info": "Product label is coded CP523A. Lot numbers include: I0625120 expiration 2011-08, and I0627120-01 expiration 2011-08.", "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": "121 boxes (12/box) Lot I0625120, and 121 boxes (12/box) Lot I0627120-01", "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": [ "K022410", "K121413", "K122374", "K073096", "K190707", 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