{
  "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": "204051",
      "product_res_number": "Z-0414-2024",
      "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",
        "K181684",
        "K183413",
        "K896819"
      ],
      "product_description": "TruWave with Vamp System Pressure monitoring set, \nREF: PXAVMP(3cc)/VAMP 68 in (173cm)\nPXAVMP3: x3 (3cc)/VAMP\nPXVK0364:(3cc)/VAMP 96in (241cm);\nPXVK0853: x3 (3cc)/VAMP 76in (193cm);\nPXVK0996:(3cc)/VAMP 68in (174cm);\nPXVMP2X21: x2 (3cc)/VAMP;\nPXVMP2X22: x2 (3cc)/VAMP 63 in (160cm);\nPXVMP3X32: x3 (3cc)/VAMP 75in (190cm);\nPXVP0041: (3cc)/VAMP Plus 96in (244cm);\nPXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm);\nPXVP1071: x3 (3cc)/VAMP Plus 87in (221cm);\nPXVP1087: x4(3cc)/VAMP Plus;\nPXVP2260: (3cc)/VAMP Plus 60in (150cm);\nPXVP2272: (3cc)/VAMP Plus 72in (180cm);\nPXVP2284: (3cc)/VAMP Plus 84in (210cm);\nPXVP2284AT3: (3cc)/VAMP Plus 84in (210cm);\nPXVP23X3: x3: (3cc)/VAMP Plus;\nPXVP23X3AT3: x3 (3cc)/VAMP Plus;\nPXVP2X2AT3: x2 (3cc)/VAMP Plus;\nPXVPL0111: (3cc)/VAMP Plus 84in (213cm);\nPXVMP160: 3cc/VAMP 60 in (150cm);\nPXVMP172: 3cc/VAMP 72in)180cm);\nPXVMP184:3cc/VAMP 84in (210cm);\nPXVMP260:3cc/VAMP 60in (150cm);\nPXVFL10017: (3cc)/VAMP Flex 83in (210cm);\nPXVP0034: (3cc)/VAMP Plus 87in (220cm);\nT001691A: (3cc)/VAMP Plus;\nT001691M: (3cc)/VAMP Plus (215cm);\nT001744M:(3cc)/VAMP 93in (236 cm);\nT100671M: x3(3cc)/VAMP Plus (215cm);\nT001760A :x2(3cc)/VAMP Plus;\nT001765A: (3cc)/60in (150cm);\nT005021M: (3cc)/VAMP Flex (195cm);\nT005089M: x2 (3cc)/VAMP Flex (195 cm) ;\nT005091M: x3(3cc)/VAMP Flex (195cm);\nT434501B: x2(3cc)/VAMP 88in (225cm);\nT440B26B: x2 (3cc)/VAMP 88in (225cm);\nT450545A: x3 (3cc)/VAMP 75in (190cm);\nT460241A: (3cc)/VAMP Plus 69in (175cm);\nT530219D: x2 (3cc)/VAMP Plus 65in (165cm)",
      "code_info": "PXAVMP:UDI: 00690103011494/Lot # 64817849;\nPXAVMP3: UDI:07460691950085/Lot # 64918575;\nPXVK0364:UDI:07460691954526/Lot # 64858007;\nPXVK0853: UDI: 07460691957671/Lot # 65060361;\nPXVK0996:UDI: 07460691955431/Lot # 64858275;\nPXVMP2X21:UDI: 07460691950115/Lot # 64992080;\nPXVMP2X22: UDI: 00690103016765/Lot # 64891427;\nPXVMP3X32:UDI: 0690103016802/Lot # 65008748;\nPXVP0041: UDI: 00690103197983/Lot # 64835537;\nPXVP0550:UDI: 07460691949911/Lot # 64818013, 64858077, 64891424, 64918588, 64985484;\nPXVP1071: UDI: 07460691955462/Lot # 64807998, 64807999;\nPXVP1087: UDI: 07460691957886/Lot # 65035078, 65079515;\nPXVP2260: UDI: 07460691950108/Lot # 64858071, 64858103, 64891419, 64906892;\nPXVP2272:UDI: 07460691950184/Lot # 64752261, 64906891, 65138017;\nPXVP2284: UDI: 07460691950177/Lot # 64818005, 64818008, 64818011, 64891421, 64933492, 64933493, 64964755, 64964759, 64964760, 64964761, 64998878, 65060446;\nPXVP2284AT3: UDI: 07460691950436/Lot # 64722680, 64858285, 64951434, 64980108, 64992088;\nPXVP23X3:UDI: 07460691950092/Lot # 64998879, 65060444;\nPXVP23X3AT3: UDI: 07460691950443/Lot # 64695848, 64779289, 64858072, 64858290, 64992092,65060447;\nPXVP2X2AT3: UDI:07460691950467/Lot # 64858075;\nPXVPL0111: UDI: 00690103200386/Lot # 64933462;\nPXVMP160: UDI:/Lot # 64779279, 64918578, 64933556, 64933559;\nPXVMP172: UDI:/Lot # 64835579;\nPXVMP184:UDI:/Lot # 64949045, 64983460, 65042811;\nPXVMP260:UDI:/Lot # 64629075, 64964750, 64980101;\nPXVFL10017:UDI:00690103210798/Lot # 64923241;\nPXVP0034:UDI:00690103197945/Lot # 64835538, 65019842;\nT001691A:UDI: 07460691947627/Lot # 64793360\t64807977\t64817834\t64835567\t64835568\t65008739\t65019862\t65035054\t65048943;\nT001744M:UDI: 07460691959507/Lot # 64526411, 64891383;\nT100671M:UDI: 07460691959491/Lot # 64912244;\nT001760A: UDI:07460691947566/ Lot # 65008764, 65019890, 65067580;\nT001765A: UDI:07460691947290/ Lot # 64891376, 64906871, 64980035, 64983290, 65035029;\nT005021M:UDI:07460691959538/ Lot # 64858230, 64923245;\nT005089M:UDI:07460691959545/Lot #64933442, 65060364\nT005091M:UDI:07460691959552/Lot # 64807926\nT434501B:UDI: 07460691956636/ Lot # 64817812\nT440B26B:UDI:07460691949553/ Lot # 64817809, 64817936;\nT450545A:UDI: 07460691931572/ Lot # 65035081;\nT460241A: UDI:07460691949188/ Lot # 64933451;\nT530219D:UDI:07460691948259/ Lot # 65067546",
      "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": "168,014 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": {
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}