Device product
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Z-2364-2016
Product summary
- Event
- Event 74581
- Status
- Terminated
- Classification
- Class II
- Quantity
- 395
- Official record key
device-enforcement:Z-2364-2016
Official wording
Reason: The rear gradation scale was screen printed upside down on the flowmeter gauge.
Code information: Serial numbers for Model IRCPF16: 16BF023724, 16BF023729, 16BF023734, 16BF023739, 16BF023744,16BF023720, 16BF023725, 16BF023730, 16BF023735, 16BF023740, 16BF023745,16BF023721, 16BF023726, 16BF023731, 16BF023736, 16BF023741, 16BF023746,16BF023722, 16BF023727, 16BF023732, 16BF023737, 16BF023742, 16BF023747,16BF023723, 16BF023728, 16BF023733, 16BF023738, 16BF023743, 16BF023748,16BF023749, 16BF030593, 16CF015205, 16CF019539, 16CF026064, 16CF030100,16BF023750, 16BF030594, 16CF015206, 16CF019540, 16CF026065, 16CF030101,16BF023751, 16CF016169, 16CF015207, 16CF019541, 16CF026066, 16CF030102,16BF023752, 16CF016170, 16CF015208, 16CF019542, 16CF026067, 16CF030103,16BF023753, 16CF016171, 16CF015209, 16CF019543, 16CF026068,16CF030104,16BF023754, 16CF016172, 16CF015210, 16CF019544, 16CF026069, 16CF030105,16BF023755, 16CF016173, 16CFOI5211, 16CF019545, 16CF026070, 16CF030106,16BF025606, 16CF016174, 16CF015212, 16CF019546, 16CF026071, 16CF030107,16BF025607, 16CF016175, 16CFOI5213, 16CF019547, 16CF026072, 16CF030108,16BF025608, 16CF016176, 16CF015214, 16CF019548, I6CF026073, 16CF030109,16BF025609, 16CF016177, 16CF015215, 16CF019549, l6CF026074, 16CF030110,16BF025610, 16CF016178, 16CF015216, l6CF019550, l6CF026075, 16CF0301ll,16BF025611, 16CF016179, 16CF018612, 16CF019551, 16CF026076, 16CF030112,16BF025612, 16CF016180, 16CF018613, 16CF019552, l6CF026077, 16CF030113,16BF025613, 16CF016181, 16CF018614, 16CF019553, 16CF026078, 16CF030114,16BF025614, 16CF016182, 16CF018615, 16CF019554, 16CF026079, 16CF030115,16BF025615, 16CF016183, 16CF018616, 16CF019555, 16CF026080, l6CF030116,16BF025616, 16CF016184, 16CF018617, 16CF019556, 16CF026081, 16CF030117,16BF025617, 16CF016185, 16CF018618, 16CF019557, 16CF026082, 16CF030118,16BF025618, 16CF016186, 16CF018619, 16CF019558, 16CF026083, 16CF030119,16BF025619, 16CF016187, 16CFOI8620, 16CF019559, 16CF026084, 16CF030120,16BF025620, 16CF016188, 16CF018621, 16CF019560, 16CF026085, 16CF030121,16BF025621, 16CF016189, 16CF018622, 16CF019561, 16CF026086, 16CF030122,16BF025622, 16CF016190, 16CF018623, 16CF019562, 16CF026087, 16CF030123,16BF025623, 16CF016191, 16CF018624, 16CF019563, 16CF026088, 16CF030124,16BF025624, 16CF016192, 16CF018625, 16CF019564, 16CF026089, 16CF032012,16BF025625, 16CF016193, 16CF018626, 16CF019565, 16CF026090, 16CF032013,16BF025626, 16CF016194, 16CF018627, 16CF019566, 16CF026091, 16CF032014,16BF025627, 16CF016195, 16CF018628, 16CF023329, 16CF026092, 16CF032015,16BF025628, 16CF016196, 16CF018629, 16CF023330, 16CF027673, 16CF032016,16BF025629, 16CF016197, 16CF018630, 16CF023331, 16CF027674, 16CF032017,16BF025630, 16CF016198, 16CF018631, 16CF023332, 16CF027675, 16CF032018,16BF025631, 16CF015181, 16CF018632, 16CF023333, 16CF027676, 16CF032019,16BF025632, 16CF015182, 16CF018633, 16CF023334, 16CF027677, 16CF032020,16BF025633, 16CF015183, 16CF018634, 16CF023335, 16CF027678, 16CF032021,16BF025634, 16CF015184, 16CF018635, 16CF023336, 16CF027679, 16CF032022,16BF025635, 16CF015185, 16CF018636, 16CF023337, 16CF027680, 16CF032023,16BF025636, 16CF015186, 16CF018637, 16CF023338, 16CF027681, 16CF032024,16BF025637, 16CF015187, 16CF018638, 16CF023339, 16CF027682, 16CF032025,16BF025638, 16CF015188, 16CF018639, 16CF023340, 16CF027683, 16CF032026,16BF025639, 16CF015189, 16CFOI8640, 16CF023341, 16CF027684, 16CF032027,16BF025640, 16CF015190, 16CF018641, 16CF023342, 16CF027685, 16CF032028,16BF025641, 16CF015191, 16CF018642, 16CF023343, 16CF027686, 16CF032029,16BF027950, 16CF015192, 16CF018643, 16CF023344, 16CF027687, 16CF032030,16BF027951, 16CF015193, 16CF018644, 16CF023345, 16CF027688, 16CF040048,16BF027952, 16CF015194, 16CF018645, 16CF023346, 16CF030089, 16CF040049,16BF030583, 16CF015195, 16CF018646, 16CF023347, 16CF030090, 16CF040050,16BF030584, 16CF015196, 16CF018647, 16CF023348, 16CF030091, 16CF040051,16BF030585, 16CF015197, 16CF019531, 16CF023349, 16CF030092, 16CF040052,16BF030586, 16CF015198, 16CF019532, 16CF026057, 16CF030093, 16CF040053,16BF030587, 16CF015199, 16CF019533, 16CF026058, 16CF030094, 16CF040054,16BF030588, 16CF015200, 16CF019534, 16CF026059, 16CF030095, 16CF040055,16BF030589, 16CF015201, 16CF019535, 16CF026060, 16CF030096, 16CF040056,16BF030590, 16CF015202, 16CF019536, 16CF026061, 16CF030097, 16CF040057,16BF030591, 16CF015203, 16CF019537, 16CF026062, 16CF030098, 16CF040058,16BF030592, 16CF015204, 16CF019538, 16CF026063, 16CF030099, 16CF040059,16CF040060,16CF040061,16DF017166, 16DF017167, 16DF017910,16DF017911, 16DF040084 16DF040085, 16DF040632,16DF040633, 16DF045327,16DF045328,16CF040062, 16DF017168, 16DF017912, 16DF040086, 16DF040634, 16DF045329,16CF040063, 16DF017169, 16DF017913, 16DF040087, 16DF040635, 16DF045330,16CF040064, 16DF017170, 16DF017914, 16DF040088, 16DF040636, 16DF045331,16CF040065, 16DF017171, 16DF017915, 16DF040089, 16DF040637, 16DF045332,16CF040066, 16DF017172, 16DF017916, 16DF040090, 16DF040638, 16DF045333,16CF040067, 16DF017173, 16DF017917, 16DF040091, 16DF040639, 16DF045334,16CF040068, 16DF017174, 16DF017918, 16DF040092, 16DF040640, 16DF045335,16CF040069, 16DF017175, 16DF017919, 16DF040093, 16DF040641, 16DF045336,16CF040070, 16DF017176, 16DF017920, 16DF040094, 16DF040642, 16DF045337,16CF040071, 16DF017177, 16DF017921, 16DF040095, 16DF040643, 16DF045338,16CF040072, 16DF017178, 16DF017922, 16DF040096, 16DF040644, 16DF045339,16CF040073, 16DF017179, 16DF017923, 16DF040097, 16DF040645, 16DF045340,16CF040074, 16DF017180, 16DF017924, 16DF040098, 16DF040646, 16DF045341,16CF040075, 16DF017181, 16DF017925, 16DF040099, 16DF040647, 16DF045342,16CF040076, 16DF017182, 16DF017926, 16DF040100, 16DF040648, 16DF045343,16CF040077, 16DF017183, 16DF017927, 16DF040101, 16DF040649, 16EF000999,16CF040078, 16DF017184, 16DF017928, 16DF040102, 16DF040650, 16EF001000,16CF040079, 16DF017185, 16DF017929, 16DF040103, 16DF041832, 16EF001001,16CF040080, 16DF017186, 16DF019605, 16DF040104, 16DF041833, 16EF001002,16CF040081, 16DF017187, 16DF019606, 16DF040615, 16DF041834, 16EF001003,16CF040082, 16DF017894, 16DF019607, 16DF040616, 16DF045311, 16EF001004,16CF040083, 16DF017895, 16DF040069, 16DF040617, 16DF045312, 16EF001005,16DF017152, 16DF017896, 16DF040070, 16DF040618, 16DF045313, 16EF001006,16DF017153, 16DF017897, 16DF040071, 16DF040619, 16DF045314, 16EF001007,16DF017154, 16DF017898, 16DF040072, 16DF040620, 16DF045315, 16EF001008,16DF017155, 16DF017899, 16DF040073, 16DF040621, 16DF045316, 16EF001009,16DF017156, 16DF017900, 16DF040074, 16DF040622, 16DF045317, 16EF001010,16DF017157, 16DF017901, 16DF040075, 16DF040623, 16DF045318, 16EF001011,16DF017158, 16DF017902, 16DF040076, 16DF040624, 16DF045319, 16EF001012,16DF017159, 16DF017903, 16DF040077, 16DF040625, 16DF045320, 16EF001013,16DF017160, 16DF017904, 16DF040078, 16DF040626, 16DF045321, 16EF001014,16DF017161, 16DF017905, 16DF040079, 16DF040627, 16DF045322, 16EF001015,16DF017162, 16DF017906, 16DF040080, 16DF040628, 16DF045323, 16EF001016,16DF017163, 16DF017907, 16DF040081, 16DF040629, 16DF045324, 16EF001017,16DF017164, 16DF017908, 16DF040082, 16DF040630, 16DF045325, 16EF001020,16DF017165, 16DF017909, 16DF040083, 16DF040631, 16DF045326, 16EF001021.
Distribution pattern: Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.
Derived failure modes
-
Unknown
The rear gradation scale was screen printed upside down on the flowmeter gauge.