{ "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": "139866", "product_res_number": "Z-0241-2016", "event_date_initiated": "2015-08-31", "event_date_posted": "2015-11-06", "recall_status": "Terminated", "event_date_terminated": "2016-04-12", "res_event_number": "72098", "product_code": "LRO", "product_description": "DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: \r\n\r\nTOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03", "code_info": "REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436", "firm_fei_number": "1043214", "recalling_firm": "DeRoyal Industries Inc", "address_1": "200 Debusk Ln", "city": "Powell", "state": "TN", "postal_code": "37849-4703", "additional_info_contact": "William G. Pittman\n865-362-2901", "reason_for_recall": "Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.", "root_cause_description": "Other", "action": "DeRoyal initiated their recall on 08/31/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete and return the spreadsheet of how many they labeled. They were asked to return the spreadsheet even if they did not have inventory. 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