Skip to content

Ivenix Infusion System recallZ-1313-2023 · Fresenius Kabi USA, LLC · initiated Mar 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

FDA root cause category: Process control

What the company is doing

The firm distributed via email a URGENT - Medical Device Recall notification to consignees identifying all large volume pumps (LVP) of the Ivenix Infusion System as requiring repair or replacement due to potential fluid ingress, which could lead to interrupted infusion of medication. Customers are instructed to have a secondary LVP readily available when the device is being used to deliver life-sustaining medication if the provided troubleshooting instructions do not resolve the cessation of infusion. Additionally, customers are to ensure no buildup of liquid on the Air Detector region surfaces by wiping away any fluid buildup and reloading the cassette if the LVP exhibits an alert. Additional instructions were provided based upon varying clinical situations and should be posted above each nursing station where the device is in use. Fresenius will be contacting their customers to arrange service in response to this recall event. Adverse events or quality problems should be reported to Fresenius at [email protected]. Customers are asked to return the Customer Reply Form provided with the recall notification and to forward the recall notice to any customers/satellite locations at which recalled devices were further distributed.

Recall details

Recall number
Z-1313-2023
Status
Open, Classified
Initiated by the company
Mar 10, 2023
Posted by the FDA
Apr 18, 2023
Recalling firm
Fresenius Kabi USA, LLC
Quantity
1,546 units
Product code
FRN
FDA submissions
K183311
Distribution
Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.

Product description

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Code information (models, lots, serial numbers)

Show the full code information (19k characters)

UDI-DI: 00811505030320; Serial No.: 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300424, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439, 2119300440, 2119300442, 2124300049, 2124300051, 2124300052, 2124300053, 2124300054, 2124300058, 2124300059, 2124300060, 2124300061, 2124300062, 2124300063, 2124300064, 2124300065, 2124300066, 2124300068, 2124300069, 2124300070, 2124300072, 2124300074, 2124300075, 2124300076, 2124300077, 2124300078, 2124300080, 2124300082, 2124300083, 2124300084, 2124300085, 2124300086, 2124300087, 2124300089, 2124300090, 2124300091, 2124300093, 2124300094, 2124300096, 2124300097, 2124300099, 2124300100, 2124300101, 2124300102, 2124300103, 2124300104, 2124300106, 2124300107, 2124300108, 2124300109, 2124300110, 2124300111, 2124300112, 2124300113, 2124300114, 2124300116, 2124300119, 2124300120, 2124300121, 2124300122, 2124300123, 2124300124, 2124300125, 2124300126, 2124300127, 2124300128, 2124300129, 2124300130, 2124300131, 2124300132, 2124300133, 2124300134, 2124300135, 2124300136, 2124300137, 2124300138, 2124300140, 2124300141, 2124300142, 2124300143, 2124300144, 2124300145, 2124300146, 2124300147, 2124300148, 2124300150, 2124300151, 2124300152, 2124300153, 2124300154, 2124300155, 2124300156, 2124300157, 2124300159, 2124300160, 2124300161, 2124300162, 2124300164, 2124300166, 2124300167, 2124300168, 2124300170, 2124300171, 2124300172, 2124300174, 2124300175, 2124300176, 2124300177, 2124300178, 2124300179, 2124300181, 2124300182, 2124300183, 2124300184, 2124300185, 2124300186, 2124300187, 2124300188, 2125900426, 2125900427, 2125900428, 2125900429, 2125900431, 2125900432, 2125900434, 2125900435, 2125900436, 2125900437, 2125900438, 2125900440, 2125900441, 2125900442, 2125900444, 2125900447, 2125900448, 2125900449, 2125900450, 2125900451, 2125900452, 2125900453, 2125900454, 2125900456, 2125900458, 2125900459, 2125900462, 2125900463, 2125900464, 2125900465, 2125900466, 2125900467, 2125900468, 2125900469, 2125900472, 2125900473, 2125900474, 2125900475, 2125900476, 2125900477, 2125900478, 2125900479, 2125900480, 2125900483, 2125900484, 2125900485, 2125900486, 2125900489, 2125900490, 2125900491, 2125900492, 2125900493, 2125900494, 2125900496, 2125900497, 2125900498, 2125900499, 2125900500, 2125900501, 2125900502, 2125900503, 2125900504, 2125900505, 2125900506, 2125900509, 2125900510, 2125900513, 2125900514, 2125900515, 2125900516, 2125900518, 2125900519, 2125900521, 2125900524, 2125900525, 2125900526, 2125900528, 2125900529, 2125900531, 2125900532, 2125900533, 2125900534, 2125900535, 2125900536, 2125900537, 2125900538, 2125900539, 2125900540, 2125900541, 2125900542, 2125900543, 2125900544, 2125900545, 2125900546, 2125900548, 2125900549, 2125900550, 2125900551, 2125900552, 2125900553, 2125900554, 2125900556, 2125900557, 2125900558, 2125900559, 2125900560, 2125900561, 2125900562, 2125900563, 2125900564, 2125900565, 2125900566, 2125900567, 2125900568, 2125900569, 2125900570, 2125900571, 2125900573, 2125900574, 2125900575, 2125900576, 2125900578, 2125900580, 2125900581, 2125900582, 2125900583, 2125900584, 2125900585, 2125900586, 2125900587, 2125900588, 2125900589, 2125900590, 2125900591, 2125900592, 2125900593, 2125900595, 2125900596, 2125900597, 2125900598, 2125900599, 2125900600, 2125900601, 2125900602, 2125900605, 2125900606, 2125900607, 2125900609, 2125900610, 2125900611, 2125900612, 2125900613, 2125900616, 2125900617, 2125900618, 2125900619, 2125900620, 2125900621, 2125900622, 2125900624, 2130700826, 2130700827, 2130700828, 2130700829, 2130700830, 2130700831, 2130700834, 2130700835, 2130700836, 2130700838, 2130700839, 2130700840, 2130700841, 2130700843, 2130700845, 2130700846, 2130700847, 2130700848, 2130700849, 2130700850, 2130700851, 2130700852, 2130700853, 2130700855, 2130700856, 2130700858, 2130700859, 2130700860, 2130700861, 2130700863, 2130700864, 2130700865, 2130700866, 2130700867, 2130700868, 2130700869, 2130700870, 2130700871, 2130700872, 2130700873, 2130700874, 2130700875, 2130700876, 2130700878, 2130700879, 2130700880, 2130700881, 2130700883, 2130700884, 2130700885, 2130700886, 2130700887, 2130700888, 2130700889, 2130700891, 2130700892, 2130700893, 2130700894, 2130700895, 2130700897, 2130700898, 2130700900, 2130700901, 2130700902, 2130700903, 2130700905, 2130700906, 2130700908, 2130700909, 2130700910, 2130700911, 2130700912, 2130700913, 2130700914, 2130700915, 2130700916, 2130700917, 2130700918, 2130700919, 2130700920, 2130700921, 2130700922, 2130700923, 2130700924, 2130700926, 2130700927, 2130700928, 2130700929, 2130700930, 2130700931, 2130700932, 2130700933, 2130700934, 2130700935, 2130700936, 2130700937, 2130700939, 2130700942, 2130700943, 2130700944, 2130700945, 2130700946, 2130700948, 2130700949, 2130700950, 2130700951, 2130700952, 2130700953, 2130700954, 2130700955, 2130700957, 2130700958, 2130700959, 2130700960, 2130700961, 2130700962, 2130700963, 2130700964, 2130700966, 2130700967, 2130700969, 2130700970, 2130700971, 2130700972, 2130700973, 2130700974, 2130700975, 2130700976, 2130700977, 2130700978, 2130700979, 2130700980, 2130700982, 2130700983, 2130700984, 2135000501, 2135000502, 2135000503, 2135000504, 2135000505, 2135000507, 2135000509, 2135000510, 2135000511, 2135000512, 2135000513, 2135000514, 2135000515, 2135000516, 2135000517, 2135000519, 2135000520, 2135000521, 2135000523, 2135000524, 2135000525, 2135000526, 2135000527, 2135000528, 2135000529, 2135000531, 2135000532, 2135000533, 2135000534, 2135000535, 2135000536, 2135000537, 2135000538, 2135000540, 2135000541, 2135000542, 2135000543, 2135000544, 2135000545, 2135000546, 2135000547, 2135000548, 2135000549, 2135000550, 2135000554, 2135000555, 2135000556, 2135000557, 2135000558, 2135000559, 2135000560, 2135000561, 2135000562, 2135000563, 2135000564, 2135000565, 2135000566, 2135000567, 2135000568, 2135000570, 2135000571, 2135000572, 2135000573, 2135000574, 2135000575, 2135000576, 2135000578, 2135000579, 2135000581, 2135000582, 2135000583, 2135000584, 2135000585, 2135000586, 2135000587, 2135000588, 2135000589, 2135000590, 2135000591, 2135000592, 2135000593, 2135000594, 2135000595, 2135000597, 2135000598, 2135000599, 2135000600, 2135000601, 2135000602, 2135000603, 2135000604, 2135000605, 2135000607, 2135000608, 2135000610, 2135000612, 2135000613, 2135000614, 2135000615, 2135000616, 2135000617, 2135000619, 2135000620, 2135000621, 2135000622, 2135000623, 2135000624, 2135000625, 2135000627, 2135000628, 2135000629, 2135000631, 2135000632, 2135000633, 2135000634, 2135000635, 2135000636, 2135000638, 2135000639, 2135000640, 2135000641, 2135000642, 2135000644, 2135000645, 2135000646, 2135000647, 2135000648, 2135000649, 2135000651, 2135000652, 2135000653, 2135000654, 2135000655, 2135000656, 2135000657, 2135000658, 2135000659, 2135000660, 2135000661, 2135000662, 2135000663, 2135000664, 2135000665, 2135000666, 2135000667, 2135000668, 2135000669, 2135000670, 2135000672, 2135000673, 2135000674, 2135000675, 2135000676, 2135000677, 2135000678, 2135000679, 2135000680, 2135000682, 2135000683, 2135000684, 2135000685, 2135000686, 2135000687, 2135000688, 2135000689, 2135000690, 2135000691, 2135000692, 2135000693, 2135000694, 2135000695, 2135000696, 2135000697, 2135000698, 2135000699, 2135000700, 2135000701, 2135000702, 2135000703, 2135000705, 2135000706, 2135000707, 2135000708, 2135000709, 2135000710, 2135000711, 2135000712, 2135000714, 2135000715, 2135000716, 2135000717, 2135000718, 2135000720, 2135000721, 2135000722, 2135000723, 2135000724, 2135000725, 2135000726, 2135000727, 2135000728, 2135000729, 2135000730, 2135000731, 2135000732, 2135000733, 2135000734, 2135000735, 2135000737, 2135000738, 2135000739, 2135000740, 2135000741, 2135000742, 2135000743, 2135000744, 2135000745, 2135000746, 2135000747, 2135000748, 2135000749, 2135000750, 2136400556, 2136400557, 2136400558, 2136400559, 2136400561, 2136400562, 2136400563, 2136400566, 2136400567, 2136400568, 2136400569, 2136400570, 2136400571, 2136400572, 2136400573, 2136400574, 2136400576, 2136400577, 2136400578, 2136400579, 2136400581, 2136400582, 2136400583, 2136400584, 2136400585, 2136400586, 2136400587, 2136400588, 2136400589, 2136400590, 2136400591, 2136400592, 2136400594, 2136400595, 2136400596, 2136400597, 2136400598, 2136400600, 2136400601, 2136400603, 2136400604, 2136400605, 2136400606, 2136400607, 2136400608, 2136400609, 2136400610, 2136400611, 2136400612, 2136400613, 2136400614, 2136400615, 2136400616, 2136400617, 2136400618, 2136400619, 2136400620, 2136400621, 2136400622, 2136400623, 2136400624, 2136400625, 2136400626, 2136400627, 2136400628, 2136400629, 2136400630, 2136400631, 2136400632, 2136400633, 2136400634, 2136400635, 2136400636, 2136400637, 2136400638, 2136400639, 2136400640, 2136400641, 2136400642, 2136400643, 2136400644, 2136400645, 2136400646, 2136400647, 2136400648, 2136400649, 2136400650, 2136400651, 2136400652, 2136400654, 2136400655, 2136400656, 2136400657, 2136400658, 2136400659, 2136400660, 2136400661, 2136400662, 2136400663, 2136400664, 2136400665, 2136400666, 2136400668, 2136400669, 2136400670, 2136400671, 2136400672, 2136400674, 2136400675, 2136400676, 2136400677, 2136400678, 2136400679, 2136400680, 2136400682, 2136400683, 2136400684, 2136400685, 2136400686, 2136400687, 2136400688, 2136400689, 2136400690, 2136400691, 2136400692, 2136400693, 2136400694, 2136400695, 2136400696, 2136400697, 2136400698, 2136400699, 2136400700, 2136400701, 2136400702, 2136400703, 2136400704, 2136400705, 2136400707, 2136400708, 2136400710, 2136400711, 2136400712, 2136400713, 2136400714, 2136400715, 2136400717, 2136400718, 2136400719, 2136400720, 2136400721, 2136400722, 2136400723, 2136400724, 2136400725, 2136400726, 2136400727, 2136400728, 2136400729, 2136400730, 2136400731, 2136400732, 2136400733, 2136400734, 2136400735, 2136400736, 2136400737, 2136400738, 2136400739, 2136400740, 2136400741, 2136400742, 2136400743, 2136400744, 2136400746, 2136400747, 2136400748, 2136400749, 2136400750, 2136400751, 2136400752, 2136400753, 2136400754, 2136400755, 2136400757, 2136400758, 2136400760, 2136400761, 2136400762, 2136400763, 2136400765, 2136400766, 2136400767, 2136400769, 2136400770, 2136400771, 2136400772, 2136400773, 2136400774, 2136400775, 2136400776, 2136400778, 2136400779, 2136400780, 2136400781, 2136400782, 2136400783, 2136400784, 2136400785, 2136400786, 2136400787, 2136400789, 2136400790, 2136400791, 2136400792, 2136400793, 2136400794, 2136400795, 2136400796, 2136400797, 2136400798, 2136400799, 2136400800, 2136400803, 2136400804, 2201811307, 2201811308, 2201811309, 2201811310, 2201811311, 2201811312, 2201811313, 2201811314, 2201811316, 2201811318, 2201811319, 2201811321, 2201811322, 2201811323, 2201811325, 2201811326, 2201811327, 2201811328, 2201811329, 2201811330, 2201811333, 2201811334, 2201811335, 2201811336, 2201811337, 2201811338, 2201811339, 2201811340, 2201811341, 2201811342, 2201811343, 2201811344, 2201811345, 2201811346, 2201811347, 2201811348, 2201811349, 2201811350, 2201811351, 2201811352, 2201811353, 2201811354, 2201811355, 2201811356, 2201811357, 2201811358, 2201811359, 2201811360, 2201811361, 2201811362, 2201811363, 2201811364, 2201811365, 2201811366, 2201811367, 2201811369, 2201811370, 2201811371, 2201811372, 2201811373, 2201811374, 2201811375, 2201811377, 2201811378, 2201811380, 2201811381, 2201811382, 2201811383, 2201811384, 2201811385, 2201811386, 2201811387, 2201811390, 2201811391, 2201811392, 2201811393, 2201811394, 2201811395, 2201811396, 2201811397, 2201811398, 2201811399, 2201811400, 2201811401, 2201811402, 2201811403, 2201811404, 2201811405, 2201811406, 2201811407, 2201811409, 2201811411, 2201811412, 2201811413, 2201811414, 2201811415, 2201811416, 2201811418, 2201811419, 2201811420, 2201811421, 2201811422, 2201811424, 2201811426, 2201811427, 2201811428, 2201811429, 2201811430, 2201811431, 2201811432, 2201811433, 2201811434, 2201811435.2201811436, 2201811438, 2201811439, 2201811440, 2201811441, 2201811442, 2201811443, 2201811444, 2201811445, 2201811448, 2201811449, 2201811450, 2201811451, 2201811452, 2201811453, 2201811454, 2201811455, 2201811456, 2201811457, 2201811458, 2201811459, 2201811460, 2201811461, 2201811462, 2201811463, 2201811466, 2201811467, 2201811468, 2201811469, 2201811470, 2201811471, 2201811472, 2201811473, 2201811474, 2201811475, 2201811476, 2201811477, 2201811478, 2201811479, 2201811480, 2201811481, 2201811482, 2201811483, 2201811484, 2201811485, 2201811486, 2201811487, 2201811488, 2201811489, 2201811490, 2201811491, 2201811492, 2201811493, 2201811494, 2201811495, 2201811496, 2201811497, 2201811498, 2201811499, 2201811500, 2201811501, 2201811502, 2201811503, 2201811504, 2201811505, 2201811506, 2201811507, 2201811510, 2201811511, 2201811512, 2201811513, 2201811514, 2201811515, 2201811517, 2201811518, 2201811519, 2201811520, 2201811522, 2201811524, 2201811525, 2201811526, 2201811527, 2201811528, 2201811529, 2201811530, 2201811531, 2201811532, 2201811533, 2201811534, 2201811535, 2201811536, 2201811537, 2201811539, 2201811540, 2201811541, 2201811542, 2201811543, 2201811545, 2201811546, 2201811547, 2201811548, 2201811549, 2201811550, 2201811551, 2201811552, 2201811553, 2201811554, 2201811556, 2201811557, 2201811558, 2201811559, 2201811560, 2201811561, 2201811562, 2201811563, 2201811564, 2201811566, 2201811567, 2201811568, 2201811569, 2201811570, 2201811571, 2201811572, 2201811573, 2201811574, 2201811575, 2201811576, 2201811577, 2201811578, 2201811579, 2201811580, 2201811581, 2201811582, 2201811583, 2201811584, 2201811585, 2201811586, 2201811589, 2201811590, 2201811591, 2201811592, 2201811593, 2201811594, 2201811595, 2201811596, 2201811597, 2201811598, 2201811599, 2201811600, 2201811603, 2201811604, 2201811605, 2201811606, 2201811607, 2201811608, 2201811609, 2201811611, 2201811612, 2201811613, 2201811614, 2201811615, 2201811616, 2201811618, 2201811619, 2201811620, 2205900061, 2205900062, 2205900063, 2205900064, 2205900065, 2205900068, 2205900069, 2205900070, 2205900071, 2205900072, 2205900073, 2205900074, 2205900075, 2205900077, 2205900079, 2205900080, 2205900081, 2205900082, 2205900083, 2205900085, 2205900086, 2205900087, 2205900089, 2205900090, 2205900091, 2205900093, 2205900094, 2205900096, 2205900098, 2205900099, 2205900100, 2205900101, 2205900102, 2205900103, 2205900104, 2205900106, 2205900107, 2205900108, 2205900109, 2205900110, 2205900112, 2205900113, 2205900115, 2205900116, 2205900117, 2205900119, 2205900120, 2205900121, 2205900122, 2205900123, 2205900124, 2205900125, 2205900126, 2205900127, 2205900128, 2205900130, 2205900131, 2205900132, 2205900133, 2205900136, 2205900137, 2205900138, 2205900140, 2205900142, 2205900143, 2205900144, 2205900145, 2205900147, 2205900148, 2205900149, 2205900150, 2205900151, 2205900152, 2205900153, 2205900154, 2205900158, 2205900159, 2205900160, 2205900161, 2205900162, 2205900167, 2205900168, 2205900169, 2205900170, 2205900173, 2205900175, 2205900176, 2205900177, 2205900178, 2212200909, 2212200910, 2212200914, 2212200916, 2212200921, 2212200922, 2212200923, 2212200924, 2212200926, 2212200927, 2212200928, 2212200929, 2212200930, 2212200931, 2212200935, 2212200937, 2212200938, 2212200939, 2212200940, 2212200943, 2212200944, 2212200945, 2212200946, 2212200947, 2212200952, 2212200953, 2212200957, 2212200958, 2212200961, 2212200962, 2212200966, 2212200969, 2212200971, 2212200973, 2212200976, 2212200978, 2212200980, 2212200982, 2212200985, 2212200986, 2212200987, 2212200988, 2212200989, 2212200990, 2212200991, 2212200993, 2212200995, 2212200996, 2212200998, 2212201002, 2212201003, 2212201004, 2212201010, 2212201012, 2212201013, 2212201015, 2212201016, 2212201019, 2212201022, 2212201023, 2212201024, 2212201027, 2212201029, 2212201030, 2212201034, 2212201042, 2212201046, 2212201048, 2212201050, 2212201052, 2212201056, 2212201057, 2212201058, 2212201059, 2212201061, 2212201062, 2212201064, 2212201066, 2212201067, 2212201068, 2212201069, 2212201071, 2212201073, 2212201074, 2212201076, 2212201078, 2212201080, 2212201081, 2212201082, 2212201083, 2212201084, 2212201086, 2212201088, 2212201089, 2212201093, 2212201095, 2212201097, 2212201100, 2212201104, 2212201105, 2212201108, 2212201111, 2212201113, 2212201114, 2212201115, 2212201117, 2212201119, 2212201120, 2213800173, 2213800184, 2213800203, 2213800209, 2213800222, 2213800239, 2213800248, 2213800250, 2213800282, 2213800288, 2213800328, 2213800332, 2213800337, 2213800343, 2213800357, 2213800363, 2215401089, 2215401115, 2215401132, 2215401136, 2215401138, 2215401140, 2215401160, 2215401163, 2215401167, 2215401169, 2215401171, 2215401179, 2215401181, 2215401184, 2215401189, 2215401196, 2215401201, 2215401202, 2215401218, 2215401220, 2215401237, 2215401239, 2215401247, 2215401260, 2215401269, 2215401279, 2215401282, 2215401287, 2215401289, 2215401291, 2215401297, 2215401299, 2215401316, 2215401319, 2215401322, 2215401326, 2215401333, 2215401335, 2215401338, 2215401340, 2215401341, 2215401344, 2215401357, 2215401360, 2215401369, 2215401371, 2215401373, 2215401387, 2215401393, 2215401394, 2215401395, 2215401397, 2215401402, 2215401406, 2215401480, 2215401489, 2215401495, 2215401498, 2215401499, 2215401505, 2215401523, 2215401543, 2215401550, 2215401553, 2215401579, 2215401590, 2215401594, 2215401597, 2215401598, 2215401600, 2215401601, 2215401627, 2215401647, 2219200130, 2219200135, 2219200159, 2219200182, 2219200189, 2219200192, 2219200194, 2219200203, 2219200208, 2219200219, 2219200220, 2219200227, 2219200232, 2219200236, 2219200250, 2219200255, 2219200261, 2219200263, 2219200265, 2219200266, 2219200274, 2219200276, 2219200278, 2219200279, 2219200281, 2219200282, 2219200283, 2219200286, 2219200287, 2219200288, 2219200289, 2219200290, 2219200293, 2219200297, 2219200298, 2219200299, 2219200301, 2219200306, 2219200307, 2219200308, 2219200313, 2219200314, 2219200315, 2219200316, 2219200319, 2219200320, 2219200321, 2219200322, 2219200323, 2219200325, 2219200340, 2219200341, 2219200344, 2219200347, 2219200357, 2219200358, 2219200372, 2219200378, 2219200379, 2219200382, 2219200384, 2219200386, 2219200411, 2219200422, 2219200423, 2219200424, 2219200432, 2219200435, 2219200436, 2219200438, 2219200439, 2219200440, 2219200441, 2219200442, 2219200446, 2219200450, 2219200452, 2219200454, 2219200455, 2219200456, 2219200457, 2219200459, 2219200460, 2219200461, 2219200462, 2219200464, 2219200465, 2219200467, 2219200476, 2219200477, 2219200480, 2219200484, 2219200487, 2219200488, 2219200493, 2219200495, 2219200502, 2219200511.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page