{ "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": "141136", "product_res_number": "Z-0207-2016", "event_date_initiated": "2015-10-16", "event_date_posted": "2015-11-04", "recall_status": "Terminated", "event_date_terminated": "2017-11-09", "res_event_number": "72463", "product_code": "LJS", "k_numbers": [ "K112896", "K113277", "K121941", "K122854", "K132133" ], "product_description": "ARROW PICC Kit featuring Chlorag+ard Technology\nMidline Catheterization Kit\nARROW Advantage5 Pressure Injectable PICC Kit\nArrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet\nARROW Pressure Injectable JACC with Chlorag+ard Technology\nFor short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.", "code_info": "Product Codes ASK-45552-RWJ3 CDC-35541-HPK1A EU-00750-45 PL-00750 AU-00420-MAJO CDC-35541-VPS EU-02041-ML PL-00755 CDC-34041-HPK1A CDC-35552-HPK1A EU-24041-HPMSB PR-35552-HPHNM CDC-34041-VPS CDC-35552-VPS EU-24052-HPMSB PR-45563-HPHNM CDC-34052-HPK1A CDC-41563-JX1A EU-25041-HPMSB UK-00420-MID CDC-34052-VPS CDC-44041-HPK1A EU-25052-HPMSB UK-00420-RCHT CDC-35041-HPK1A CDC-44052-HPK1A EU-25063-HPMSB UK-00420-THT CDC-35041-VPS CDC-44063-HPK1A EU-25541-HPMSB UK-04041-RDEH CDC-35052-HPK1A CDC-45063-HPK1A EU-25552-HPMSB UK-05041-MSB CDC-35052-VPS CDC-45563-HPK1A IB-01652 UK-05041-RDEH CDC-35063-HPK1A EU-00740-45 PL-00740 UK-05052-RCHT", "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": "610-378-0131", "reason_for_recall": "Possibility that the catheter peel-away\ncomponent hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the\ncatheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment\nwhen placing the catheter.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Arrow International sent an Urgent Medical Device Recall Notification letter dated October 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to immediately discontinue use and quarantine any effected products. Consignees were instructed to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact consignees with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. For consignees with no affected product, should also complete the enclosed Recall Acknowledgement Form.\nFor questions customers should call 1-866-246-6990.", "product_quantity": "12,157", "distribution_pattern": "World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium.", "openfda": { "k_number": [ "K081904", "K153469", "K173956", "K932430", "K903648", "K172039", "K150448", "K180548", "K063848", "K063240", "K131687", "K152819", "K210264", "K213550", "K232594", "K970434", "K832774", "K160925", "K897168", "K051690", "K093366", "K170486", "K113808", "K073451", "K060887", "K841878", "K832580", "K070996", "K040446", "K153423", "K130034", "K072625", "K193015", "K241587", "K833442", "K964556", "K930630", "K834091", "K122423", "K831587", "K831845", "K935145", "K101326", "K171931", "K840958", "K883313", "K072391", 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