{ "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": "209997", "product_res_number": "Z-0061-2025", "event_date_initiated": "2024-08-30", "event_date_posted": "2024-10-11", "recall_status": "Open, Classified", "res_event_number": "95330", "product_code": "DXT", "k_numbers": [ "K011811" ], "product_description": "Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530\n\nInjector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.", "code_info": "Catalog Number: IN2530/B\nUDI-DI code: 00884450298060\nLot Number:\nH2305037\nH2309345\nH2312492\nH2320984\nH2326312\nH2331540\nH2337135\nH2343848\nH2348709\nH2353510\nH2379875\nH2385823\nH2398320\nH2413098\nH2416393\nH2421995\nH2426129\nH2432439\nH2435893\nH2443007\nH2446113\nH2453678\nH2457937\nH2458275\nH2466457\nH2474179\nH2483316\nH2486955\nH2492844\nH2497959\nH2503846\nH2507122\nH2511932\nH2517520\nH2522881\nH2528489\nH2534960\nH2540016\nH2545413\nH2550521\nH2554673\nH2560209\nH2564559\nH2568225\nH2574051\nH2579557\nH2584204\nH2594880\nH2594944\nH2599817\nH2604242\nH2610526\nH2614059\nH2618906\nH2622811\nH2629607\nH2633301\nH2639298\nH2645654\nH2649898\nH2655509\nH2660065\nH2664666\nH2669781\nH2672437\nH2673582\nH2683311\nH2688025\nH2693066\nH2703591\nH2713947\nH2733076\nH2746748\nH2751197\nH2760547\nH2769987\nH2774666\nH2784537\nH2789807\nH2793110\nH2801750\nH2806027\nH2810778\nH2824764\nH2834413\nH2838430\nH2845204\nH2847853\nH2849888\nH2849889\nH2856554\nH2861492\nH2867260\nH2871518\nH2880698\nH2890797\nH2907144\nH2912644\nH2918429\nH2925194\nH2929405\nH2934699\nH2937986\nH2943479\nH2978085\nH2982496\nH2989541\nH2994311\nH3000025\nH3009570", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "Merit Customer Service \n800-356-3748", "reason_for_recall": "Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.", "root_cause_description": "Nonconforming Material/Component", "action": "On 08/30/2024, the firm email and/or UPS overnight delivery an \"URGENT MEDICAL DEVICE RECALL NOTICE\" informing customers that specific lots of MONARCH Inflation Devices due to a packaging defect, there may be a small hole in the Tyvek sterile barrier of the device packaging. Use of the affected product may result in exposure to pathogens/pyrogens which could lead to infection.\n\nCustomer are instructed to:\n1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution.\n2. Ensure that applicable personnel within your organization are made aware of this field action.\n3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities.\n4. Please fill out, scan, and email the completed CRF to Customer Service at response@merit.com within 7 calendar days. All affected product shipped to you must be accounted for on the CRF.\n5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.\n\nFor questions - contact your Merit Sales Representative or Merit Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.", "product_quantity": "51,900 devices", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K182273", "K863537", "K911166", "K905819", "K033247", "K863596", "K934086", "K023183", "K182289", "K113133", "K020892", "K062168", "K000013", "K203004", "K140469", "K904212", "K061976", "K072886", "K170431", "K163084", "K844045", "K171698", "K873597", "K924116", "K140425", "K890292", "K910873", "K984088", "K875324", "K912944", "K142081", "K833138", "K142745", "K232388", "K012950", "K873410", "K911549", "K964642", "K823253", "K973230", "K051799", "K090621", "K092896", "K133189", "K171646", "K823920", "K230668", "K822536", "K971712", "K252652", "K962141", "K791793", "K082212", "K010390", "K960965", "K955685", "K252891", "K072696", "K071691", "K854310", "K152218", "K823356", "K042784", "K955381", "K875196", "K881521", "K143538", "K983826", "K133600", "K860204", "K920135", "K830754", "K252638", "K840281", "K883769", "K880987", "K093830", 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"K242143", "K090487", "K112086", "K150485", "K823191", "K152978", "K872981", "K933908", "K244038", "K850861", "K042744", "K873955", "K862547", "K951802", "K963982", "K190102", "K873687", "K241109", "K170279", "K955684", "K963071", "K902377", "K873173", "K895318", "K160190", "K833645", "K823192", "K252653", "K821401", "K884913", "K935668", "K910594", "K991557", "K904994", "K031339", "K150902", "K900034", "K944875", "K011991", "K020333", "K001663", "K993728" ], "registration_number": [ "3003898360", "3013764800", "2520313", "3003120897", "3003627840", "1000604079", "2243252", "3001650535", "9610849", "3018094310", "3013529745", "3013820501", "3014246639", "3003829571", "1526863", "1054241", "9610612", "1724474", "3004605321", "3009504230", "2032112", "3003768277", "8022210", "3007138831", "1518293", "3009196578", "3010009632", "2320762", "3004068971", "1928237", "1720929", "2134243", "3004080920", "3004111573", "3004727093", "3035858922", "2032098", "3009882464", "3008850249", "1721676", 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"1319639", "3007361214", "3015225571", "1422634", "3009746061", "3009051888", "1526711", "3007048453", "2249018" ], "fei_number": [ "3003898360", "3013764800", "1000219637", "3002807040", "2520313", "3003120897", "3003627840", "1000604079", "2243252", "3001650535", "3003076831", "3018094310", "3013529745", "3013820501", "3014246639", "3003829571", "1526863", "3000718866", "3004605321", "3009504230", "3007138831", "1000306431", "1518293", "3009196578", "3010009632", "3005747797", "3004068971", "1928237", "1720929", "3004080920", "3004111573", "3004727093", "3035858922", "3009882464", "3008850249", "1000138054", "1721676", "3004050971", "2011171", "3003542872", "1000514656", "3033589330", "3011642792", "3015173212", "1721686", "3011604145", "2936999", "2022435", "3003040625", "3010131137", "3020460367", "3002949731", "3004458261", "1038185", "3019807891", "1417592", "3015309643", "1000112877", "3003094851", "3015276088", "3003915875", "1000114111", "3003561450", "3012536737", "3003094575", "3010934635", "3002807391", "3007007790", "1526534", "3014615028", "3045750327", "3006791331", "2523676", "3015183635", "3012127758", "1625425", "3010665433", "1043214", "3016096098", "3004753774", "3932", "3014498725", "1643817", "3013413516", "2027111", "3007289408", "3010041511", "3015910259", "3002807880", "3015009200", "1000512168", "3012085143", "3002806315", "1721504", "3008918179", "3008692839", "1047843", "3042190142", "3004056159", "1018470", "3006950086", "3012044688", "1043729", "3003786696", "3003058448", "3001726808", "3009763019", "2020394", "3007084575", "3031503890", "3034544377", "3020298301", "1000123180", "1000208624", "1000112968", "3012395857", "2521402", "3002808086", "3011334555", "3007361214", "3015225571", "3002963732", "3009746061", "3009051888", "1526711", "3007048453" ], "device_name": "Injector And Syringe, Angiographic", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }