Product Safety Recalls

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Baxter Healthcare Corporation Recall 88695

Description: Hemodialysis Delivery System, Software Version 2.x.

Baxter Healthcare Corporation Recall 88695 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0215-2022
Event ID88695
Event DescriptionHemodialysis Delivery System, Software Version 2.x.
Product TypeDevices
DistributionDistributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Quantity4248
Recall ReasonIf the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
Device Classification20211117
Device Code InfoSoftware Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378, 107379, 107380, 107381, 107382, 107383, 107384, 107385, 107386, 107387, 107483, 107484, 107485, 107486, 107487, 107488, 107489, 107490, 107491, 107492, 107493, 107494, 107495, 107496, 107497, 107498, 107499, 107500, 107501, 107502, 107503, 107504, 107505, 107506, 107507, 107508, 107509, 107510, 107511, 107512, 107818, 107819, 107820, 107821, 107822, 107823, 107824, 107825, 107826, 107827, 107878, 107879, 107880, 107881, 107882, 107883, 107884, 107885, 107886, 107887, 108193, 108194, 108195, 108196, 108197, 108198, 108199, 108200, 108201, 108202, 108203, 108204, 108205, 108206, 108207, 108208, 108209, 108210, 108211, 108212, 108303, 108304, 108305, 108306, 108307, 108308, 108309, 108310, 108311, 108312, 108453, 108454, 108455, 108456, 108457, 108458, 108459, 108460, 108461, 108462, 108503, 108504, 108505, 108506, 108507, 108508, 108509, 108510, 108511, 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Center Classification Date20211111
Recall Initiation Date20210929
Termination Date3, 109834, 109835, 109836, 109837, 109838, 109839, 109840, 109841, 109842, 109843, 109844, 109845, 109846, 109847, 109848, 109849, 109850, 109851, 109852, 109853, 109854, 109855, 109856, 109857, HVER14, HVER16, HVER3, HVER36, HVER45, HVER5); Product Code: 955627, UDI: 07332414124700 (Lot/Serial #109702, 109703, 109704, 109705, 109706, 109707, 109708, 109709); Product Code: 955701, UDI: 7332414125844 (Lot/Serial #104448, 104449, 104450, 104451, 104452, 104453, 104454, 104455, 104466, 104467, 104468, 104469, 104470, 104471, 104472, 104473, 104474, 104475, 105646, 105647, 105648, 105649, 105650, 105651, 105652, 105653, 107275, 107276, 107277, 107278, 107279, 107280, 107281, 107282, 107283, 107284, 107285, 107286, 107287, 107898, 107899, 104446, 104447, 107900, 107901, 107902, 107903, 107904, 107905, 107906, 107907, 107908, 107909, 107910, 107911, 107912, 107913, 107914, 107915, 107916, 107917, 107918, 107919, 107920, 107921, 107922, 108513, 108514, 108515, 108516, 108517, 108518, 108519, 108520, 108521, 108522, 108563, 108564, 108565, 108566, 108567, 108568, 108569, 108570, 108571, 108572, 108573, 108574, 108575, 108576, 108577, 108578, 108579, 108580, 108581, 108582, 108603, 108604, 108605, 108606, 108607, 108608, 108609, 108610, 108611, 108612, 108613, 108614, 108615, 108616, 108617, 108618, 108619, 108620, 108621, 108622, 108685, 108686, 108687, 108688, 108689, 108690, 108691, 108692, 108693, 108694, 108695, 108696, 108979, 108980, 108981, 108982, 108983, 108984, 108985, 108986, 108987, 108988, 108989, 108990, 108991, 108992, 108993, 108994, 108995, 108996, 108997, 108998, 108999, 109000)
Recalling FirmBaxter Healthcare Corporation
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