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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0294-2013

EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.

Publicado el 21 de noviembre de 2012 · Inicio del retiro: 8 de noviembre de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
MOOG Medical Devices Group
Distribuidor
Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
Lote
INFKIT2 with serial numbers: 506249031, 506264096, 506272024, 506335006, 506335145, 506336089, 506336096, 506362083, 506362086, 507018037, 507018060, 507067220, 507085140, 507087018, 507087140, 507095089, 507095171, 507121102, 507122050, 507122066, 507123149, 507123163, 507144016, 507144057, 507144215, 507144220, 507144221, 507144226, 507151002, 507155019, 507155021, 507155094, 507155127, 507155156, 507155159, 507156065, 507157048, 507157124, 507164009, 507173005, 507173019, 507173063, 507179123, 507180064, 507186018, 507186098, 507186176, 507197012, 507197024, 507197036, 507201013, 507201038, 507205054, 507206064, 507212012, 507212013, 507214065, 507214098, 507214162, 507215041, 507218016, 507219057, 507219087, 507219103, 507220106, 507221098, 507227116, 507229033, 507229039, 507229060, 507232030, 507236063, 507236203, 507236303, 507239056, 507241089, 507242130, 507242201, 507247049, 507248031, 507248087, 507248095, 507249131, 507250175, 507255025, 507257123, 507257129, 507261065, 507264041, 507264127, 507268121, 507268351, 507268374, 507269084, 507270096, 507270106, 507271157, 507275046, 507276154, 507278013, 507281028, 507281055, 507283119, 507284158, 507285186, 507289004, 507289120, 507289157, 507289165, 507291090, 507291168, 507291232, 507292108, 507292179, 507292339, 507295099, 507306069, 507311133, 507313050, 507313057, 507313059, 507313084, 507325044, 507330149, 507337080, 507337082, 507337085, 507339076, 507339095, 507344149, 507345001, 507345103, 507347150, 507348077, 507351090, 507353065, 507353120, 508018015, 508018090, 508030083, 508037024, 508037097, 508039099, 508039101, 508058001, 508058159, 508058160, 508066002, 508066030, 508066097, 508066123, 508066152, 508066153, 508066268, 508067033, 508067069, 508067092, 508067117, 508067166, 508067229, 508067231, 508070062, 508070228, 508071060, 508071132, 508071257, 508072146, 508072151, 508077022, 508099062, 508100033, 508112135, 508112159, 508114018, 508114111, 508116029, 508126038, 508131043, 508131079, 508131084, 508137099, 508137101, 508148152, 508148165, 508148216, 508148267, 508151050, 508151121, 508159063, 508165023, 508165034, 508165060, 508165231, 508166036, 508172055, 508172218, 508172260, 508172319, 508172334, 508198263, 508198264, 508199105, 508233083, 508233103, 508234066, 508234068, 508234078, 508234086, 508235009, 508235107, 508235111, 508235124, 508255070, 508255100, 508260115, 508260216, 508262074, 508263073, 508269064, 508275020, 508289015, 508289131, 508325051, 508326036, 508326058, 508340030, 508340100, 508351216, 508351237, 508351246, 508357105, 509005203, 509005218, 509008108, 509008270, 509008308, 509009120, 509015017, 509017118, 509020024, 509020140, 509021098, 509024156, 509030043, 509030055, 509030056, 509030088, 509034103, 509035272, 509054126, 509055029, 509055207, 509065195, 509065202, 509065212, 509071109, 509072019, 509072092, 509079210, 509085268, 509086084, 509086125, 509090011, 509090127, 509099077, 509100122, 509107033, 509119090, 509119120, 509120121, 509132033, 509141115, 509162073, 509183062, 509183092, 509197148, 509209048, 509231116, 509254016, 509258007, 509258203, 509274074, 509275014, 509281008, 509282068, 509285043, 509323066, 509324035, 509324059, 509344048, 509350005, 509350020, 509350025, 509350037, 509350072, 509350078, 509350084, 510015134, 510015149, 510015166, 510027107, 510027146, 510028041, 510050026, 510050094, 510063025, 510063107, 510076044, 510076045, 510088038, 510092021, 510124007, 510124012, 510128125, 510168018, 510168043, 510188065, 510193159, 510218008, 510218038, 510218051, 510218064, 510218066, 510218071, 510218084, 510218087, 510218097, 510218098, 510218106, 510218148, 510218156, 510221001, 510221003, 510221028, 510221087, 510222003, 510222005, 510222006, 510222011, 510222013, 510222016, 510222020, 510222032, 510222062, 510222112, 510222119, 510222121, 510229001, 510229002, 510229003, 510229004, 510229005, 510229006, 510229007, 510229008, 510229009, 510229010, 510229011, 510229012, 510229013, 510229014,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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