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FDAFDA · Food and drugs·Recall number 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.

Published September 28, 2016 · Recall initiated: March 8, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

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

Recall details

Manufacturer
Hospira Inc.
Distributor
United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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