Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

Hazard

The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.

Details from the source

Reason for recall: The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death. Distribution: US distribution to states of: CA, CO, NJ, UT, and WI. Quantity: 938 US Lot/code info: UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212201118 2212201115 2212201113 2212201111 2212201100 2212201095 2212201093 2212201088 2212201076 2212201074 2212201061 2212201059 2212201046 2212201029 2212201024 2212201003 2212201002 2212200993 2212200990 2212200987 2212200986 2212200982 2212200978 2212200958 2212200952 2212200945 2212200938 2212200929 2212200914 2205900177 2205900176 2205900170 2205900167 2205900158 2205900152 2205900150 2205900143 2205900133 2205900132 2205900128 2205900126 2205900125 2205900113 2205900112 2205900110 2205900109 2205900108 2205900107 2205900106 2205900098 2205900096 2205900094 2205900091 2205900090 2205900074 2205900072 2205900071 2205900067 2205900062 2205900061 2201811620 2201811615 2201811614 2201811605 2118200011 2201811603 2201811600 2201811598 2201811597 2201811596 2201811594 2201811590 2201811585 2201811584 2201811582 2201811579 2201811577 2201811568 2201811567 2201811561 2201811560 2119300422 2201811554 2119300424 2201811550 2201811549 2201811548 2201811545 2201811542 2201811541 2119300431 2201811539 2201811533 2119300434 2119300435 2119300436 2119300437 2119300438 2201811532 2201811530 2201811529 2119300442 2201811527 2201811526 2201811524 2124300052 2201811520 2201811519 2201811517 2201811514 2201811510 2201811507 2201811503 2124300060 2201811499 2201811493 2201811488 2201811484 2201811482 2201811481 2201811479 2201811477 2201811476 2201811474 2201811471 2201811467

UPC codes

00811505030320

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.