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Recall Observatory FDA recall evidence

Device product

FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.

Z-0412-2024

October 04, 2023

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 93279
Status
Ongoing
Classification
Class II
Quantity
11,072 units
Official record key
device-enforcement:Z-0412-2024

Official wording

Reason: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information: MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224; MHD6C502: UDI: 00690103194760, Lot #: 64951410

Distribution pattern: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.