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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2873-2016

LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.

Publicado el 28 de septiembre de 2016 · Inicio del retiro: 8 de marzo de 2013

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

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Hospira Inc.
Distribuidor
United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
Lote
Serial Number 15553367, 16224548, 16224939, 16225091, 16225646, 16225851, 16226006, 16226095, 16226117, 16226159, 16226360, 16226383, 16226435, 16226460, 16226680, 16226707, 16226726, 16226730, 16226756, 16226763, 16226891, 16226895, 16226898, 16226910, 16226917, 16226918, 16226919, 16226920, 16226921, 16226922, 16226923, 16226924, 16226925, 16226926, 16226927, 16226928, 16226929, 16226930, 16226931, 16226932, 16226933, 16226934, 16226935, 16226936, 16226937, 16226938, 16226939, 16226940, 16226941, 16226943, 16226944, 16226945, 16226946, 16226947, 16226948, 16226949, 16226950, 16226951, 16226952, 16226953, 16226954, 16226955, 16226956, 16226957, 16226958, 16226959, 16226960, 16226961, 16226962, 16226963, 16226964, 16226965, 16226966, 16226967, 16226968, 16226969, 16226970, 16226971, 16226972, 16226973, 16226974, 16226975, 16226976, 16226977, 16226978, 16226979, 16226980, 16226981, 16226982, 16226983, 16226984, 16226985, 16226986, 16226987, 16226988, 16226989, 16226990, 16226991, 16226992, 16226993, 16226994, 16226995, 16226996, 16226997, 16226998, 16226999, 16227000, 16227001, 16227002, 16227003, 16227004, 16227005, 16227006, 16227007, 16227008, 16227009, 16227010, 16227011, 16227012, 16227013, 16227014, 16227015, 16227016, 16227017, 16227018, 16227019, 16227020, 16227021, 16227022, 16227023, 16227024, 16227026, 16227027, 16227028, 16227029, 16227030, 16227031, 16227032, 16227033, 16227035, 16227036, 16227038, 16227039, 16227040, 16227041, 16227042, 16227043, 16227044, 16227045, 16227046, 16227047, 16227048, 16227049, 16227050, 16227051, 16227052, 16227053, 16227054, 16227055, 16227056, 16227057, 16227058, 16227059, 16227061, 16227062, 16227063, 16227064, 16227065, 16227066, 16227067, 16227068, 16227069, 16227070, 16227071, 16227072, 16227073, 16227074, 16227075, 16227076, 16227077, 16227078, 16227079, 16227080, 16227082, 16227083, 16227084, 16227085, 16227086, 16227087, 16227088, 16227089, 16227090, 16227091, 16227092, 16227093, 16227094, 16227095, 16227096, 16227097, 16227098, 16227099, 16227100, 16227101, 16227102, 16227103, 16227104, 16227105, 16227106, 16227107, 16227108, 16227109, 16227110, 16227111, 16227112, 16227113, 16227114, 16227115, 16227116, 16227117, 16227119, 16227120, 16227122, 16227123, 16227124, 16227125, 16227126, 16227127, 16227128, 16227129, 16227130, 16227131, 16227132, 16227133, 16227134, 16227135, 16227136, 16227138, 16227139, 16227140, 16227141, 16227142, 16227143, 16227144, 16227145, 16227146, 16227147, 16227148, 16227149, 16227150, 16227151, 16227152, 16227153, 16227154, 16227155, 16227156, 16227157, 16227158, 16227159, 16227160, 16227161, 16227162, 16227163, 16227164, 16227165, 16227166, 16227167, 16227168, 16227169, 16227170, 16227171, 16227172, 16227173, 16227174, 16227175, 16227176, 16227177, 16227178, 16227179, 16227180, 16227181, 16227182, 16227183, 16227184, 16227185, 16227186, 16227187, 16227188, 16227189, 16227190, 16227191, 16227192, 16227193, 16227194, 16227195, 16227196, 16227197, 16227198, 16227199, 16227200, 16227201, 16227202, 16227203, 16227204, 16227205, 16227206, 16227207, 16227208, 16227209, 16227210, 16227211, 16227212, 16227213, 16227214, 16227215, 16227216, 16227217, 16227218, 16227219, 16227220, 16227221, 16227222, 16227223, 16227224, 16227225, 16227226, 16227227, 16227228, 16227229, 16227230, 16227231, 16227232, 16227233, 1
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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