{ "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": "30008", "product_res_number": "Z-0138-04", "event_date_initiated": "2003-10-01", "event_date_posted": "2003-11-19", "recall_status": "Terminated", "event_date_terminated": "2004-02-02", "res_event_number": "27525", "product_code": "DXT", "k_numbers": [ "K884913" ], "product_description": "IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL'', Latex free. Sterile if package is unopened or undamaged. Part # 1525/B", "code_info": "Lot # A285003.", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc", "address_1": "1600 Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "Stephanie Erskine\n801-208-4349", "reason_for_recall": "There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.", "root_cause_description": "Other", "action": "Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.", "product_quantity": "626 units", "distribution_pattern": "Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.", "openfda": { "k_number": [ "K230668", "K863037", "K132928", "K140425", "K170279", "K923117", "K172694", "K090621", "K143538", "K901382", "K873410", "K875324", "K152218", "K880493", "K800823", "K042784", "K112086", "K211564", "K863537", "K152906", "K052633", "K190102", "K131478", "K880877", "K140469", "K884913", "K170431", "K991557", "K993728", "K152978", "K880987", "K252638", "K120892", "K991103", "K823254", "K973230", "K955381", "K963071", "K823190", "K896415", "K232388", "K880310", "K142745", "K964642", "K833645", "K823253", "K082212", "K142081", "K010390", "K790835", "K113133", "K001663", "K791782", "K173773", "K840281", "K900034", "K171698", "K023183", "K020333", "K242212", "K902475", "K071691", "K191060", "K882329", "K902221", "K871129", "K911166", "K050456", "K150485", "K033881", "K033247", "K082439", "K031483", "K161471", "K161505", "K113198", "K182276", "K971712", "K873955", "K910873", "K933846", 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