{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167478", "product_res_number": "Z-0282-2019", "event_date_initiated": "2018-08-30", "event_date_created": "2018-10-26", "recall_status": "Terminated", "event_date_terminated": "2020-07-31", "res_event_number": "81117", "product_code": "FOZ", "k_numbers": [ "K993691" ], "product_description": "Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites, Central venous pressure monitoring, Total parenteral nutrition (TPN), Infusions of fluids, medications, or chemotherapy, and Frequent blood sampling or receiving blood transfusions/blood products.", "code_info": "23F16C0071", "firm_fei_number": "3015859709", "recalling_firm": "Arrow International Inc", "address_1": "2400 Bernville Rd", "city": "Reading", "state": "PA", "postal_code": "19605-9607", "additional_info_contact": "Customer Service\n866-396-2111", "reason_for_recall": "The product was\nshipped after its expiry date due to a system error. The product lidstock identifies the\ncorrect expiration date however the accompanying purchase order shipping\ndocumentation identifies an incorrect expiration date. Per standard clinical practice the\nlidstock would most likely be checked prior to use and the product would not be used\nleading to a minor delay while a replacement is located. In the unlikely event that the\nproduct lidstock is not checked prior to use, there is potential for use of expired\nproduct, and product functionality/or sterility cannot be guaranteed.", "root_cause_description": "Under Investigation by firm", "action": "On August 29, 2018, the firm notified customers via an Urgent Medical Device Recall letter. The letter informed customers of the product issue.\n\nCustomers were advised to do the following: \n\n1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above, so that the affected products can be returned to Arrow.\n2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International.\n3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter.\n\nIf you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.", "product_quantity": "105", "distribution_pattern": "US nationwide in the states of CA, FL, NC, and RI.", "openfda": { "k_number": [ "K984059", "K874582", "K213085", "K060174", "K961552", "K932946", "K213664", "K840862", "K132153", "K220626", "K840815", "K050114", "K170283", "K150611", "K000632", "K190001", "K023253", "K883415", "K930048", "K111366", "K933467", "K133280", "K990236", "K840355", "K130518", "K142136", "K895734", "K011860", "K881976", "K834227", "K912358", "K962938", "K991406", "K813374", "K081953", "K970736", "K902527", "K020785", "K052564", "K141026", "K811171", "K161779", "K834255", "K140270", "K823017", "K032843", "K974543", "K003187", "K780105", "K760163", "K923323", "K905009", "K032777", "K881215", "K163358", "K950301", "K850398", "K875082", "K954112", "K953252", "K113565", 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