{ "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": "129628", "product_res_number": "Z-0033-2015", "event_date_initiated": "2014-08-25", "event_date_posted": "2014-10-07", "recall_status": "Terminated", "event_date_terminated": "2017-03-10", "res_event_number": "69085", "product_code": "LJS", "k_numbers": [ "K042061", "K121990", "K131038" ], "product_description": "PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- \n\nIntended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.", "code_info": "Batch/Lot No. 4754052 (exp. 30-Apr-15)", "firm_fei_number": "3017892510", "recalling_firm": "Navilyst Medical, Inc", "address_1": "10 Glens Falls Technical Park", "city": "Glens Falls", "state": "NY", "postal_code": "12801", "additional_info_contact": "Mr. Michael Duerr\n518-742-4571", "reason_for_recall": "NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.", "root_cause_description": "Nonconforming Material/Component", "action": "BD Medical sent an Urgent Voluntary Medical Device Recall letter dated July 22, 2014, to all affected customers via Federal Express on August 25, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and quarantine all affected product. Immediately discontinue shipment of the affected product. Complete the Recall Response Card form and fax it back to BD at 1-201-847-6990. If the affected product was further distributed cusotmers should identify their cusotmers and notify them immediately of the product recall. Customers with questions were instructed to contact BD Customer Service at 1-888-237-2762, option 3.\nFor questions regarding this recall call 518-742-4571.", "product_quantity": "60 units/pouches", "distribution_pattern": "Nationwide Distribution", "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", 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"device_name": "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days", "medical_specialty_description": "General Hospital", "regulation_number": "880.5970", "device_class": "2" } } ] }