{ "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": 332 } }, "results": [ { "cfres_id": "203280", "product_res_number": "Z-0001-2024", "event_date_initiated": "2023-08-10", "event_date_posted": "2023-10-05", "recall_status": "Open, Classified", "res_event_number": "93014", "product_code": "LJS", "k_numbers": [ "K153487" ], "product_description": "Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter", "code_info": "Batch/Lot number 33F23B0781", "firm_fei_number": "3013162291", "recalling_firm": "ARROW INTERNATIONAL Inc.", "address_1": "3015 Carrington Mill Blvd", "city": "Morrisville", "state": "NC", "postal_code": "27560-5437", "reason_for_recall": "This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.", "root_cause_description": "Under Investigation by firm", "action": "Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: \nMedical facilities: \nImmediately cease use and distribution of affected product and quarantine for return.\nDistributors: \nImmediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. \nFirm is requesting return of the affected product.", "product_quantity": "1173 units", "distribution_pattern": "US", "openfda": { "k_number": [ "K003110", "K960055", "K141634", "K841878", "K993614", "K832774", "K910486", "K935380", "K093252", "K072391", "K162441", "K843450", "K950987", "K971999", "K130897", "K921755", "K053345", "K061179", "K093775", "K954302", "K121990", "K161765", "K973057", "K041088", "K163452", "K192246", "K031626", "K021704", "K132567", "K833915", "K130034", "K920755", "K935145", "K882448", "K910315", "K051102", "K110627", "K001874", "K034020", "K883313", "K232571", "K082481", "K892926", "K150448", "K112744", "K980090", "K050931", "K162443", "K113225", "K073451", "K123617", "K030255", "K091953", "K061289", "K232594", "K072509", "K071875", "K961155", "K844080", "K153469", "K954720", "K153423", "K141151", "K070002", "K142616", "K243484", "K832580", "K840958", "K122545", "K871998", "K233149", 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