{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "106928", "product_res_number": "Z-0895-2012", "event_date_initiated": "2012-01-09", "event_date_posted": "2012-01-26", "recall_status": "Terminated", "event_date_terminated": "2016-02-05", "res_event_number": "60909", "product_code": "LJS", "k_numbers": [ "K093406" ], "product_description": "AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104813 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804\n\nindicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.", "code_info": "FG Lot Number: 553213", "firm_fei_number": "3008319439", "recalling_firm": "Angiodynamics Worldwide Headquarters", "address_1": "14 Plaza Drive", "city": "Latham", "state": "NY", "postal_code": "12110-3421", "additional_info_contact": "David Greer\n518-795-1676", "reason_for_recall": "The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.", "root_cause_description": "Nonconforming Material/Component", "action": "AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product.\nComplete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. \nIf customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. \nFor any questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.", "product_quantity": "55 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K953256", "K172899", "K232571", "K142889", "K131687", "K121941", "K082481", "K954720", "K241587", "K180548", "K172511", "K983412", "K953436", "K041468", "K851243", "K143238", "K093366", "K051690", "K921755", "K092306", "K883313", "K210264", "K844080", "K961336", "K180567", "K930630", "K932433", "K031129", "K050931", "K122423", "K061289", "K895543", "K897168", "K113277", "K150448", "K993052", "K840742", "K042491", "K112896", "K926293", 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