{ "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": "141501", "product_res_number": "Z-0268-2016", "event_date_initiated": "2015-10-28", "event_date_created": "2015-11-12", "recall_status": "Terminated", "event_date_terminated": "2016-08-17", "res_event_number": "72550", "product_code": "DWF", "k_numbers": [ "K012538" ], "product_description": "Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide.\nThe Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.", "code_info": "Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346,  209704347,210010558    TL7M64R3 209789393 TL7P17R1 209789333", "firm_fei_number": "1000116158", "recalling_firm": "Medtronic Perfusion Systems", "address_1": "7611 Northland Dr N", "city": "Brooklyn Park", "state": "MN", "postal_code": "55428-1088", "additional_info_contact": "Medtronic Representative\n800-633-8766", "reason_for_recall": "This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.", "root_cause_description": "Packaging process control", "action": "Medtronic sent an Urgent Medical Device Recall letter dated October 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were advised to quarantine and return all affected product and to complete and return the Customer Confirmation certificate. For questions contact your Medtronic representative or contact Medtronic's national Answering service at 800-633-8766.", "product_quantity": "496", "distribution_pattern": "Nationwide Distribution including US: AL, IL, IN, and WI.", "openfda": { "k_number": [ "K203057", "K971019", "K801359", "K983270", "K061832", "K880779", "K881330", "K881074", "K880103", "K840914", "K042156", "K081820", "K881072", "K831759", "K873212", "K152190", "K884393", "K844139", "K896778", "K130639", "K180453", "K802261", "K000274", "K801770", "K850385", "K953945", "K801401", "K964193", "K890024", "K831332", "K990772", "K203067", "K961270", "K813037", "K781990", "K042984", "K162215", "K111147", "K182586", "K140569", "K002366", "K790565", "K842375", "K031037", "K033463", "K862634", "K971291", "K040173", "K122913", "K001565", "K022042", "K974736", "K792070", "K061254", "K013944", "K253203", "K792202", "K843542", "K801398", "K861310", "K001961", "K792152", "K922471", "K831591", "K052372", "K013013", "K041650", 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