FDAFDA · Food and drugs·Recall number 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.
Published February 6, 2013 · Recall initiated: October 12, 2012
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MOOG Medical Devices Group
- Distributor
- Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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