{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "148877", "product_res_number": "Z-0714-2017", "event_date_initiated": "2016-06-08", "event_date_created": "2016-12-07", "recall_status": "Terminated", "event_date_terminated": "2018-06-15", "res_event_number": "74948", "product_code": "LJS", "k_numbers": [ "K142616" ], "product_description": "Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014\nThe Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated 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. Non-Valve lumens are indicated for central venous pressure monitoring", "code_info": "Lot #: 4941411", "firm_fei_number": "3017892510", "recalling_firm": "Angiodynamics Inc. (Navilyst Medical Inc.)", "address_1": "10 Glens Falls Tech Park", "city": "Glens Falls", "state": "NY", "postal_code": "12801-3864", "additional_info_contact": "Gary Barrett\n518-792-4112", "reason_for_recall": "There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.", "root_cause_description": "Mixed-up of materials/components", "action": "Angiodynamics, Inc. (Navilyst Medical, Inc.) sent an Urgent Voluntary Medical Device Recall letter dated June 8, 2016, with reply forms to all affected customers. Customers were advised to immediately remove any affected product from inventory, segregate and secure in a location for return. Immediately forward a copy of the recall notification to all sites to which they have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 8am-7pm, EST Monday - Friday to obtain a replacement or credit for your returned product. Promptly complete, sign and return the Reply Verification Tracking Form by email to recall@angiodynamics.com or by Fax to 1-800-782-1357.\nFor questions regarding this recall call 518-792-4112.", "product_quantity": "48 cartons (boxes of 5)", "distribution_pattern": "Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX", "openfda": { "k_number": [ "K970434", "K142889", "K123759", "K142267", "K153487", "K092347", "K093252", "K061240", "K220363", "K993442", "K193015", "K971999", "K834473", "K892926", "K951098", "K051672", "K241910", "K932464", "K152409", "K833915", "K241587", "K840958", "K963215", "K122882", "K132885", "K230669", "K851243", "K061986", "K060887", "K133634", "K070996", "K091466", "K101329", "K003642", "K141634", "K964556", "K923653", "K063848", "K971085", "K830256", "K882448", "K041088", "K030255", "K010349", "K063363", "K963257", "K131942", "K100635", "K243458", "K141633", "K042491", "K843450", "K123617", "K964929", "K102966", "K081904", "K172039", 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