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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0764-2013

Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.

Publicado el 6 de febrero de 2013 · Inicio del retiro: 12 de octubre 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

The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
MOOG Medical Devices Group
Distribuidor
Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
Lote
List number: INFKIT2 Lot/Serial numbers: 105068015, 105068002, 105068014, 105068013, 105068012, 105068011, 105068009, 105068008, 105068007, 105066024, 105066021, 105068003, 105068005, 105068006, 105066004, 105068027, 105068028, 105068026, 105068019, 105068020, 105068031, 105068037, 105068023, 105068025, 105068034, 105068018, 105068017, 105068016, 105068033, 105068032, 105068030, 105068029, 105068036, 105068035, 105068022, 105068038, 105069005, 105069004, 105069003, 105069002, 105069001, 105069008, 105069007, 105069006, 105068039, 105068040, 105068041, 105069009, 105069014, 105069013, 105069012, 105069010, 105069011, 105070009, 105070008, 105070001, 105070010, 105070011, 105070003, 105070004, 105070005, 105070006, 105070007, 105069024, 105069023, 105069018, 105069025, 105069017, 105070002, 105069015, 105080001, 105070012, 105070013, 105070015, 105070016, 105070017, 105070018, 105070019, 105070020, 105070021, 105070022, 105080004, 105080002, 105081007, 105081027, 105081033, 105081002, 105081001, 105081013, 105081011, 105081010, 105081009, 105081008, 105081039, 105081006, 105080012, 105080013, 105080014, 105080015, 105080016, 105081034, 105081035, 105081030, 105081032, 105080017, 105081018, 105080018, 105080019, 105080020, 105080021, 105080006, 105081029, 105081025, 105081021, 105081023, 105081019, 105081022, 105081036, 105081028, 105081026, 105081016, 105081014, 105081003, 105081017, 105081004, 105081020, 105081024, 105080007, 105080008, 105080009, 105081005, 105080010, 105081040, 105073001, 105073006, 105073005, 105073007, 105073003, 105073004, 105073008, 105070023, 105070025, 105070026, 105066032, 105069016, 105073002, 105080005, 105080003, 105082005, 105082007, 105082006, 105082008, 105082004, 105082001, 105082002, 105081050, 105081049, 105081044, 105081048, 105081045, 105081046, 105082009, 105081041, 105082012, 105082011, 105082010, 105082046, 105082055, 105082049, 105083007, 105083008, 105083010, 105082054, 105082041, 105083001, 105083002, 105082047, 105083003, 105083004, 105083005, 105083006, 105082050, 105082052, 105082051, 105082048, 105082044, 105082015, 105082014, 105082013, 105082016, 105082018, 105082019, 105082030, 105082034, 105082028, 105082037, 105082033, 105082032, 105082020, 105082040, 105082035, 105082025, 105082023, 105082022, 105082021, 105082027, 105082026, 105082039, 105082029, 105082038, 105082031, 105083013, 105083012, 105083011, 105083014, 105083017, 105083016, 105083015, 105083019, 105083018, 105083020, 105087007, 105087020, 105087026, 105087008, 105087011, 105083037, 105087021, 105087023, 105087003, 105083038, 105087014, 105083041, 105087016, 105087013, 105087015, 105087024, 105087010, 105087018, 105087019, 105087017, 105087002, 105087012, 105087004, 105087027, 105087005, 105087006, 105087022, 105083036, 105087025, 105083040, 105090008, 105089009, 105089003, 105089013, 105090001, 105089012, 105089008, 105090007, 105090005, 105089010, 105089016, 105089006, 105089015, 105089002, 105089007, 105090003, 105090004, 105090002, 105090006, 105089005, 105083028, 105083026, 105083027, 105063019, 105088026, 105063020, 105088012, 105088007, 105088004, 105087038, 105088011, 105088010, 105088001, 105088022, 105088003, 105087039, 105088006, 105088018, 105088017, 105088016, 105088002, 105088021, 105088020, 105088008, 105088025, 105088015, 105063018, 105088014, 105088027, 105088024, 105088023, 105088009, 105087036, 105087034, 105087037, 105088013, 105088019, 105088028, 105083029, 105083031, 105083034, 105083032, 105083035, 105083030, 105083033, 105087029, 105087032, 105087030, 105087031, 105087028, 105087033, 105083021, 105083022, 105088032, 105088033, 105088029, 105088030, 105088035, 105088038, 105088036, 105088034, 105088031, 105088037, 105088040, 105088039, 105088042, 105088043, 105088041, 105090009, 105083024, 105083023, 105083025, 105088044, 105090010, 105087029, 105087032, 105087030, 105087031, 105087028, 105087033, 105090012, 105090013, 105090014, 105090016, 105090017, 105090020, 105090018, 105090019, 10509002
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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