{ "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": "205402", "product_res_number": "Z-0844-2024", "event_date_initiated": "2023-12-21", "event_date_posted": "2024-01-29", "recall_status": "Open, Classified", "res_event_number": "93768", "product_code": "GAR", "k_numbers": [ "K981582" ], "product_description": "Surgilon Braided Nylon sutures:\n\n88861919-31 SURGILON* 4-0 BLK 7X75CMPCT\n88861919-41 SURGILON* 3-0 BLK 7X75CMPCT\n88861919-51 SURGILON* 2-0 BLK 7X75CMPCT\n88861919-71 SURGILON* 1 BLK 7X75CM PCT", "code_info": "Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT\nUDI-DI 10884521071728, 20884521071725\nLots\nD1L1929RY\nD2B2243RY\n\nModel 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT\nUDI-DI 10884521071742, 20884521071749\nLot\nD2B0176RY\n\nModel 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT\nUDI-DI 10884521071766\nLots\nD2D2437RY\nUDI-DI 20884521071763\nLots\nD2D2437RY\nD2E0905RY\nD2E0916RY\n\nModel 88861919-71 SURGILON* 1 BLK 7X75CM PCT\nUDI-DI 20884521071794\nLots\nD1M0640RY\nD1M1494RY", "firm_fei_number": "1282497", "recalling_firm": "Covidien LP", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "Technical Service\n800-962-9888 Ext. 2", "reason_for_recall": "Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.", "root_cause_description": "Process control", "action": "On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters. \n\nCustomers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor.\n\nPass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed.\n\nIf you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1\n\n***Updated 4/1/2024***\nFirm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024.", "product_quantity": "46,812 US; 68,976 OUS", "distribution_pattern": "Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.", "openfda": { "k_number": [ "K904052", "K052900", "K943223", "K904931", "K926168", "K042367", "K931612", "K032160", "K161633", "K030177", "K912429", "K913102", "K220980", "K920510", "K905286", "K212603", "K922530", "K212888", "K024090", "K960327", "K000539", "K943216", "K993998", "K042284", "K990090", "K261484", "K041510", "K052482", "K981582", "K060528", "K930586", "K943222", "K931613", "K900531", "K031531", "K023028", "K053637", "K152795", "K903177", "K003000", "K931914", "K930943", "K993970", "K123034", "K994176", "K930517", "K020146", "K060471", "K905379", "K081366", "K981322", "K001173", "K903029", "K926587", "K932037", "K192420", "K151165" ], "pma_number": [ "N85316", "N80838", "N85060", "N83511" ], "registration_number": [ "3013403214", 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"2523835", "3029754081", "3006562124", "2245304", "1055236", "2032098", "1064584", "2521877", "3016904853", "3007791573", "3016426842", "3012101664", "3003267729", "3006981798", "1930126", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "3012342459", "2246552", "2085887", "2244478", "1064017", "1062668", "3004060107", "3030446844", "3003915875", "1221051", "1064514", "2030624", "1054241", "9680794", "3010162973", "3011137372", "2320762", "3006425876", "3014579161", "3020983460", "9614747" ], "fei_number": [ "3013403214", "3002807390", "3014117096", "3002902735", "1000219637", "3005747797", "2210968", "3002957101", "3001236905", "3013298431", "3001738911", "3012026312", "3015183635", "3014592276", "3003040625", "3011560638", "3008912461", "3000206435", "3017196117", "2648623", "3029835193", "3001639746", "3004215117", "2183301", "3015330532", "3044819802", "3009513193", "1111225", "3002692886", "3002807041", "3029901632", "3000302153", "3014276972", "3014615644", 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"3004845555", "3012342459", "2246552", "3004060107", "3030446844", "3003915875", "1221051", "3006425876", "3014579161", "3020983460" ], "device_name": "Suture, Nonabsorbable, Synthetic, Polyamide", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5020", "device_class": "2" } } ] }