{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "192372", "product_res_number": "Z-0921-2022", "event_date_initiated": "2022-03-11", "event_date_created": "2022-04-13", "recall_status": "Open, Classified", "res_event_number": "89760", "product_code": "MAV", "k_numbers": [ "K961471" ], "product_description": "20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)", "code_info": "Part Numbers: 1000184 Device Identifier-GTIN: 08717648013591 Lot Numbers: 60309678 60320071 60337162 60311336 60320899 60337166 60311338 60331726 60311337 60311339 60331727 60317539 60315914 60334491 60318209 60317535 60334492", "firm_fei_number": "2024168", "recalling_firm": "Abbott Vascular", "address_1": "26531 Ynez Rd", "city": "Temecula", "state": "CA", "postal_code": "92591-4630", "additional_info_contact": "Alicia Swanson\n408-845-3427", "reason_for_recall": "Due to an increase in complaint trend for leaks and intermittent/loose connections.", "root_cause_description": "Component change control", "action": "On 03/11/2022, the firm sent an \"URGENT FIELD SAFETY NOTICE/DEVICE RECALL\" Letter via visit, email or mail, to customers informing them that specific lots of 20/30 INDEFLATOR, INDEFLATOR Plus 30 and associated Priority Packs my exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum.\n\nCustomers are instructed to:\n1)Immediately stop using the devices from the affected lots\n2) Review their inventory, complete and return the provided Effectiveness Check Form\n3) Return all unused affected devices to the Recalling Firm\n4) Share the Recall Notification with relevant personnel in their organization\n5) if the affected products have been further distributed/transferred, notify those customers\n6) Report any occurrence of product performance issues or patient adverse events to the Recalling Firm at 800-227-9902\n\nThe Recalling Firm:\n-Has immediately stop shipping devices from affected lots\n-Conducting an investigation to determine/confirm that there are not other affected products or lots in distribution\n-Implementing appropriate corrective actions to ensure product performance\n-Will work to replace inventory when available\n\nFor questions or assistance contact the local representative or customer service department at 800-227-9902", "product_quantity": "17 lots", "distribution_pattern": "U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI.\n\nO.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation,\nBahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama", "openfda": { "k_number": [ "K130566", "K962495", "K843448", "K940425", "K853136", "K921757", "K153038", "K042449", "K953676", "K140943", "K260035", "K102648", "K140745", "K910958", "K123214", "K910205", "K961471", "K812304", "K922573", "K895836", "K912544", "K903503", "K953522", "K832323", "K220773", "K913994", "K861607", "K942269", "K040138", "K940896", "K955869", "K904954", "K143522", "K993341", "K012480", "K904508", "K060643", "K082755", "K921719", "K904394", "K903621", "K896005", "K120694", "K943597", "K902695", "K122152", "K162272", "K896849", "K911295", "K122321", "K952566", "K960983", "K912644", "K152387", "K904275", "K153672", "K895511", "K133795" ], "registration_number": [ "3027815", "1043214", "2020394", "3011050570", "1060680", "3004091615", "1825146", "1018233", "9610612", "3005099803", "3003898360", "3010149039", "9681260", "3002807314", "3015225571", "3010872792", "1721504", "1054241", "3006950086", "3012536737", "1526863", "3015309643", "1043729", "1319639", "3010041511", "1018470", "3014461810", "3010131137", "1928237", "1724474", "1820334", "9616684", "1721676", "2124215", "1644312", "3004111573", "3030446844", "1047843", "3022815697", "3006942524", "3007695715", "3010291427", "3011137372", "3033589330", "3004859241", "2024168", "1000121056", "1220452", "3014579161", "3006082230", "3010141307", "1055236", "3005580113", "3007361214", "2939561", "3007830707", "3024893679", "3005941719", "3007138831", "1625425", "2011171", "1721686", "3007048453" ], "fei_number": [ "1043214", "2020394", "3002807111", "3011050570", "3004091615", "1000138054", "1825146", "1018233", "3005099803", "3003898360", "3010149039", "3003094851", "3002807314", "3015225571", "3010872792", "1721504", "3006950086", "3012536737", "1000112968", "1526863", "3015309643", "1043729", "1000112877", "3010041511", "3014461810", "1018470", "3010131137", "1928237", "1820334", "1721676", "3004635528", "2124215", "3004111573", "3030446844", "3002806315", "1047843", "3022815697", "1000127185", "3006942524", "3007695715", "3010291427", "3002806565", "1000117748", "3033589330", "3004859241", "2024168", "1000121056", "3002913962", "3014579161", "1220452", "3006082230", "3010141307", "3005580113", "3007361214", "3007830707", "3024893679", "3007138831", "1625425", "3005747797", "2011171", "1000208624", "1721686", "3007048453" ], "device_name": "Syringe, Balloon Inflation", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }