{ "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": "183431", "product_res_number": "Z-0037-2021", "event_date_initiated": "2020-08-03", "event_date_created": "2020-10-01", "recall_status": "Terminated", "event_date_terminated": "2022-09-08", "res_event_number": "86254", "product_code": "GAM", "k_numbers": [ "K120556" ], "product_description": "Velosorb Fast Braided Absorbable Suture:\n\nCovidien Velosorb 0 Undyed 36\" GS-11 Cutting\tCV4731,\tUDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.", "code_info": "Lot Number:  20060204X", "firm_fei_number": "3006981798", "recalling_firm": "Riverpoint Medical, LLC", "address_1": "825 NE 25th Ave", "city": "Portland", "state": "OR", "postal_code": "97232-2304", "additional_info_contact": "Doug King\n503-517-8001", "reason_for_recall": "The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.", "root_cause_description": "Under Investigation by firm", "action": "On 08/03/2020, the firm notified affected customer via email using a letter titled, \"URGENT: MEDICAL DEVICE RECALL\" indicating that the customer should do the following:\n\n- Immediately examine inventory and quarantine product subject to the recall.\n- Discontinue selling product listed above and return any existing stock to the firm.\n- Complete and return the enclosed response form as soon as possible via email. Mark the return shipments with the RGA number.\n- Provide recall information to any customers to whom you may have distributed or forwarded affected product. Customer may include a copy of this recall notice with your customer notification.\n\nIf you have any questions, call the firm at (503) 517-8001.", "product_quantity": "1256", "distribution_pattern": "US 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", 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