{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197315", "product_res_number": "Z-0782-2023", "event_date_initiated": "2022-11-30", "event_date_posted": "2023-01-04", "recall_status": "Open, Classified", "res_event_number": "91235", "product_code": "HNN", "product_description": "Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. \nPart Number: 376630", "code_info": "UDI: 00886158100010 \nLot Number: 3391035 \n\nAdditionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035", "firm_fei_number": "1211998", "recalling_firm": "Beaver Visitec International, Inc.", "address_1": "500 Totten Pond Rd 10 City Point", "city": "Waltham", "state": "MA", "postal_code": "02451-1916", "additional_info_contact": "SAME\n781-906-7950", "reason_for_recall": "Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection", "root_cause_description": "Under Investigation by firm", "action": "Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take:\n1. Immediately examine your inventory and quarantine product from the lot that is subject to this recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. Use a copy of this recall notification letter when contacting your customers. \n2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business reply form to Beavervisitec6269@sedgwick.com. \n3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. \n4. If you have any questions regarding this Field Action, please contact BVI at 888-708-5723 or Beavervisitec6269@sedgwick.com. If you have affected product, please return product with copy of BRF to: \nReturn your product to STERICYCLE using the enclosed UPS pre-paid return label:\nAttn: Event 6269 Stericycle \n2670 Executive Drive, Suite A, Indianapolis, IN 46241 \nCredit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com and include in the subject line: Master Case PIR: 387823.", "product_quantity": "599 units (US): 410 units; 189 kits", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K831266", "K860305", "K861491", "K760187", "K791980", "K821440", "K760191", "K853403", "K781465", "K830366", "K852706", "K822112", "K840855", "K852633", "K812620", "K853063", "K861744", "K843447", "K871285", "K820618", "K864290", "K882402", "K844553", "K863665", "K791981", "K922378", "K873385", "K855050", "K852828", "K863725", "K874056", "K812918", "K874057", "K861732", "K834546", "K832844", "K860331", "K850049", "K853129", "K861748", "K760186", "K874979", "K860852", "K812450", "K860332", "K853598", "K861334", "K881669", "K831975", "K842647", "K110166", "K851790", "K853499", "K841951" ], "registration_number": [ "8010851", "3014334038", "3015895045", "3004475955", 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