{ "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": "139895", "product_res_number": "Z-0152-2016", "event_date_initiated": "2015-09-14", "event_date_posted": "2015-10-21", "recall_status": "Terminated", "event_date_terminated": "2016-05-09", "res_event_number": "72112", "product_code": "LJT", "k_numbers": [ "K830730" ], "product_description": "PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24\r\n\r\nThe Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.", "code_info": "Lot 46262", "firm_fei_number": "2183502", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "1265 Grey Fox Rd", "city": "Saint Paul", "state": "MN", "postal_code": "55112-6929", "additional_info_contact": "Customer Service\n800-258-5361", "reason_for_recall": "The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.", "root_cause_description": "Labeling mix-ups", "action": "The firm, Smiths Medical, sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated 9/14/2015 to customers. The letter described the product, problem, and actions to be taken. The customers were instructed to Inspect your inventory for and quarantine the affected product, complete and return attached Confirmation form via fax to: 1-651-747-4959 or email to: recall.response@smiths-medical.com within 10 days; upon receipt of completed form, customer representative will contact you and arrange for exchange of your unused affected product; send a copy of letter and confirmation form to your customers identified, replacement product will be arranged for your customers; provide email confirmation of your customer notification to Smiths Medical at recall.response@smiths-medical.com, and notify downstream customers who may have received the product. \r\n\r\nIf you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at 1-800-258-5361.", "product_quantity": "130 Cartons (1560 needles)", "distribution_pattern": "Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.", "openfda": { "k_number": [ "K870950", "K905842", "K875213", "K033686", "K964066", "K934802", "K022983", "K964538", "K260916", "K881075", "K994196", "K030636", "K122767", "K093414", "K190559", "K952537", "K973497", "K905851", "K952548", "K953529", "K070003", "K153359", "K871209", "K840481", "K915273", "K895871", "K953254", "K854019", "K921475", "K841150", "K090512", "K934518", "K953571", "K930206", "K924748", "K832917", "K091099", "K992880", "K153238", "K850888", "K896093", "K942623", "K934640", "K070116", "K881745", "K932095", "K921379", "K122834", "K863305", "K133335", "K832788", "K932841", "K934792", "K922896", "K032600", "K926011", "K905845", "K903691", "K924505", "K081472", "K974471", "K903364", "K952435", "K881342", "K934520", "K000125", "K081425", "K953073", "K151239", "K993024", "K952748", "K993860", "K964559", "K873213", "K942412", "K905841", "K994111", "K951872", "K122899", "K830730", "K994216", "K925373", "K073210", "K150514", 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"fei_number": [ "", "1319211", "3008537309", "3009888344", "3012494290", "3003076831", "1000138054", "1220905", "3007939342", "2245270", "3013666218", "3011534620", "3010149039", "3015859709", "3018094310", "3026560514", "2011171", "3006260740", "3002468371", "3002806713", "3042205359", "3013750125", "1450392", "1048735", "3006425876", "1000393132", "1000120555", "3010041511", "1219930", "3011237770", "1018233", "3005704822", "3003700453", "1000512168", "3008737795", "3003737899", "2518902", "2025816", "3013557562", "2246552", "3015531529", "3002807095", "3004407880", "3009746061", "3009291251", "3006082230", "3005232773", "3006942524", "3003678543", "3015537049", "3003915875", "3011088743", "3002558692", "1820334", "1000120613", "3008133910", "3000206435", "1000523114" ], "device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2" } } ] }