{ "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": "204419", "product_res_number": "Z-0627-2024", "event_date_initiated": "2023-11-06", "event_date_posted": "2024-01-02", "recall_status": "Open, Classified", "res_event_number": "93461", "product_code": "KRA", "k_numbers": [ "K172081" ], "product_description": "Merit Maestro Microcatheter, Reference Numbers: \t28MC2111045/B,\n28MC21110ST/B,\n28MC2113045/B,\n28MC21130SN/CNB,\n28MC21130ST/B,\n28MC2115045/B,\n28MC2115045/C,\n28MC21150SN/B,\n28MC21150ST/B,\n28MC2411045/D,\n28MC24110SN/D,\n28MC24110ST/D,\n28MC2413045/D,\n28MC24130SN/F,\n28MC24130ST/D,\n28MC24130ST-W/A,\n28MC2415045/D,\n28MC24150ST/D,\n28MC24150ST/F,\n28MC28110ST/D,\n28MC2813045/D,\n28MC28130SN/D,\n28MC28130SN/F,\n28MC28130ST/D,\n28MC28150SN/D,\n28MC28150SN/F,\n29MC2911045/D,\n29MC29130SN/F,\n29MC29130ST/D,\n29MC29150ST/CNB,\n29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY", "code_info": "Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215;\nRef: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239;\nRef:28MC2113045/B- Lot # H2750699, H2763805, H2775122 - UDI: 00884450335246;\nRef:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253;\nRef:28MC21130ST/B- Lot # H2750708 - UDI: 00884450335260\nRef:28MC2115045/B- Lot # H2750484 - UDI: 00884450335277\nRef:28MC2115045/C- Lot # H2750714 - UDI: 00884450442456\nRef:28MC21150SN/B- Lot # H2750715 and H2769214 00884450335284\nRef:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291\nRef:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903\nRef:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910\nRef:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927\nRef:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934\nRef:28MC24130SN/F- Lot # H2750372\t00884450358207\nRef:28MC24130ST/D- Lot # H2750747 and H2779460 UDI: 00884450357958\nRef:28MC24130ST-W/A- Lot # H2777603\t00884450324592\nRef:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965\nRef:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989\nRef:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245\nRef:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016\nRef:28MC2813045/D- Lot # H2770016- UDI: 00884450358023\nRef:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030\nRef:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290\nRef:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047\nRef:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI: \nRef:28MC28150SN/F- Lot # H2750387\tUDI: 00884450358320\nRef:29MC2911045/D- Lot # H2758290\t00884450358085\nRef:29MC29130SN/F- Lot # H2750390\t00884450358382\nRef:29MC29130ST/D- Lot # H2750599\t00884450358139\nRef:29MC29150ST/CNB- Lot # H2756603\t00884450038383\nRef:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160", "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": "Ms. Hannah Gay\n801-253-1600", "reason_for_recall": "The sterility of microcatheter and infusion system devices cannot be guaranteed.", "root_cause_description": "Package design/selection", "action": "On November 6, 2023, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via Email or UPS. Merit Medical asked consignees to take the following actions:\n\n1. 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 Customer Response Form to Customer Service at response@merit.com within seven (7) days. All affected product shipped to you must be accounted for on the CRF.\n\n5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached\nCRF.", "product_quantity": "717 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, \tKS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.", "openfda": { "k_number": [ "K010004", "K153502", "K082519", "K111490", "K101450", "K964868", "K971306", "K931335", "K993266", "K953133", "K070279", "K040139", "K230636", "K172081", "K214025", "K082613", "K072724", "K180275", "K210114", "K952874", "K951602", "K231279", "K023351", "K003925", "K951502", "K070979", "K801173", "K100892", "K161962", "K860570", "K211525", "K153501", "K132947", "K924661", "K223176", "K885281", "K062752", "K093750", "K142259", "K113773", "K111263", "K034036", "K954020", "K832058", "K914751", "K780479", "K123477", 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