{ "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": "191945", "product_res_number": "Z-0833-2022", "event_date_initiated": "2022-02-23", "event_date_created": "2022-03-30", "recall_status": "Terminated", "event_date_terminated": "2023-05-02", "res_event_number": "89561", "product_code": "HET", "k_numbers": [ "K982276" ], "product_description": "(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7\", 17.5 cm, Catalog #88-5910;\n(b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7\", 17.5 cm, Catalog #88-5920;\n(c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and\n(d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.", "code_info": "(a) Catalog #88-5910 - Lot numbers C17XRD and K17XRD, UDI 10885403153341;\n(b) Catalog #88-5920 - Lot numbers XRDX02, XRDZ07, K17XRD, C18XRD, G18XRD, C19XRD, D20XRD, G20XRD, J19XRD, K19XRD; UDI 10885403153358;\n(c) Catalog #88-9808 - Lot numbers XRDV09, G20XRD, 864909; UDI 10885403155314; and\n(d) Catalog #88-9809 - Lot numbers XRDV09, XRDV10, XRDX06, B18XRD, D18XRD, G20XRD; UDI 10885403155321.", "firm_fei_number": "3008002452", "recalling_firm": "Carefusion 2200 Inc", "address_1": "75 N Fairway Dr", "city": "Vernon Hills", "state": "IL", "postal_code": "60061-1845", "additional_info_contact": "Ms. Mary J. Ferreira\n201-847-5950", "reason_for_recall": "The finished device package did not contain the IFU.", "root_cause_description": "Nonconforming Material/Component", "action": "The recalling firm issued letters dated 2/23/2022 on the same date via email and FedEx 2 day delivery. The letter described the issue and the health hazards involved and requested the consignee to take the following actions: (1) Check all inventory locations for the affected catalog/lot numbers; (2) The IFU is provided with the letter and the consignee is requested to maintain it in the appropriate location as determined by their facility. If more than one IFU is required, the consignee is to contact BD; (3) Share the recall notice with any users of the product within their facility to ensure they are aware of the recall notification. If the product has been transferred or further distributed outside of their facility, they are requested to provide a copy of the letter to those locations; (4) Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the recall notification regardless of whether they have the affected product; and (5) Report any adverse health consequences experienced with the use of the product to BD.", "product_quantity": "152 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, IN, LA, MA, MI, MN, MS, MT, NC, NY, OH, OK, PA, TN, TX, VA, and WI. The countries of Taiwan and Australia.", "openfda": { "k_number": [ "K942389", "K910340", "K910907", "K932689", "K905759", "K151011", "K944270", "K933768", "K823295", "K902655", "K022384", "K123365", "K912398", "K946147", "K884781", "K914923", "K080365", "K852680", "K932118", "K973304", "K771959", "K771958", "K903560", "K791052", "K940265", "K933492", "K946235", "K944245", "K954520", "K897064", "K771963", "K772242", "K964450", "K920234", "K950232", "K936273", "K101458", "K915331", "K091010", "K980694", "K972488", "K930756", "K860192", "K971797", "K000199", "K935785", "K061268", "K874611", "K903124", "K904142", "K992481", "K982518", "K903780", "K951250", "K921015", "K955403", "K934506", "K873598", "K082451", "K931136", "K915338", "K020143", "K933698", "K963960", "K910579", "K210116", "K970105", "K972647", "K936071", "K962985", "K924485", "K980166", "K903600", "K201832", "K951490", "K081173", "K893715", "K915297", "K922248", "K935031", "K912882", "K942973", "K920549", "K943508", 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} } ] }