{ "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": "204031", "product_res_number": "Z-0413-2024", "event_date_initiated": "2023-10-04", "event_date_posted": "2023-11-29", "recall_status": "Open, Classified", "res_event_number": "93279", "product_code": "DRS", "k_numbers": [ "K142749", "K171996", "K183413" ], "product_description": "TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3cc)/210cm, T001658A: x2 (3cc)/180 cm, T001660A: X3 (3CC)/150CM, T001709A: X2 (3 cc)/210 cm,T001767A: (3cc)/60in (150cm), T321573A: (3cc)/66 in (165cm), T433803A (3cc)/200cm, T441T01C: (3cc)/225 cm, T494C00B: (3 cc)/180 cm,", "code_info": "PX212: UDI: 07460691950221/Lot # 65087613;\nPX260: UDI: 07460691950191/Lot #64817892, 64818036, 64818038, 64964776, 64964780;\nPX272: UDI: 07460691950207/Lot # 65067588\nPX284: UDI: 07460691950214/Lot # 64980120, 64980121, 65008760, 65019888, 65019889, 65035079;\nPX2X2: UDI: 07460691950061/Lot # 64955114, 65012789, 65027868, 65170585;\nPX3X3284C:UDI: 07460691950269/Lot # 64906878, 65007202, 65019845;\nPX4X4: UDI: 07460691950665/Lot # 64807960, 64835551, 64858629;\nPX600F: UDI: 07460691945555/Lot # 64918553, 64951413, 65016989;\nPXMK1876: UDI: 07460691953826/Lot # 64817828, 64817963;\nPXMK1940: UDI: 07460691955981/Lot # 64858039;\nPXMK2024: UDI: 07460691958180/Lot # 64964690;\nPXMK2041: UDI: 07460691951464/Lot # 64933443, 64933444;\nPXMK2321: UDI: 07460691958784/Lot # 64912231;\nPXMK2331: UDI: 07460691959224/Lot # 64933498;\nPXMK9146: UDI: 07460691954427/Lot # 64992075;\nPXMK1876: UDI: 07460691953826/Lot # 64817963;\nPXVK1099: UDI: 07460691958753 /Lot # 65067568\nPXMK0102: UDI: 00690103199932/ Lot # 65008741 \nPXMK2043: UDI: 07460691956230/ Lot # 64980031\nT001657A: UDI: 07460691902046/Lot# 64686945, 64807966, 64918558, 64948620;\nT001658A :UDI: 07460691902053/Lot #65007203, 65036124;\nT001660A: UDI: 07460691902077/Lot # 64964732, 65019857;\nT001709A: UDI: 07460691947610/Lot# 64918560, 64964727, 65079483;\nT001767A: UDI: 07460691947306/Lot # 64891376, 64906871, 64980035, 64983290, 65035029;\nT321573A: UDI: 07460691910270/Lot# 64807975;\nT433803A: UDI: 07460691926714/Lot # 64722635;\nT441T01C: UDI: 07460691928848/Lot # 64835565;\nT494C00B:UDI: 07460691950313/Lot #64807969, 64918562;", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "Linnette Torres\n949-250-6827", "reason_for_recall": "Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.", "root_cause_description": "Device Design", "action": "On 10/18/2023, Edwards Lifesciences issued a \"Urgent: Medical device Correction Action via FedEx mail. Edwards ask consignees to take the following actions: \n\n1. Follow the IFU for proper setup and flushing of your device.\n2. Follow the instructions included in the enclosed customer acknowledgement form to complete the acknowledgement process.\n3. Verify your inventory on the attached customer acknowledgement form.\n3a.E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com, within 15 days from receipt of this notification.\n4. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred.\n5. Please post a copy of this notice near and/or with affected devices.\n6. Contact Edwards Customer Service at 1-888-352-0904 if you would like to return any of your devices or have further questions.\n7. Action Requested for Distributors:\n In addition to the actions above, please forward this customer communication to any of your customers who have purchased the impacted product.", "product_quantity": "118,570 units", "distribution_pattern": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tWA\tWI\tWV\tWY\n\nOUS: Argentina\tAustralia\tAustria\tBahrain\tBelgium\tBrazil\tCanada\tCANARY ISLANDS\tChile\tColombia\tCosta Rica\tCzech Republic\tDenmark\tEcuador\tFaroe Islands\tFrance\tGermany\tGreece\tGuatemala\tHong Kong\tIndonesia\tIreland\tIsrael\tItaly\tJapan\tMalaysia\tNetherlands\tNew Zealand\tNorthern Ireland\tNorway\tPanama\tPoland\tPortugal\tSaudi Arabia\tSingapore\tSlovakia\tSlovenia\tSouth Korea\tSpain\tSweden\tSwitzerland\tUnited Arab Emirates (UAE)\tUnited Kingdom\tVietnam", "openfda": { "k_number": [ "K812758", "K851888", "K841613", 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"medical_specialty_description": "Cardiovascular", "regulation_number": "870.2850", "device_class": "2" } } ] }