Class 2 Device Recall lnvacare Precise Rx Pediatric Flowmeter

• Date Initiated by Firm: June 21, 2016
• Date Posted: August 08, 2016
• Recall Status: Terminated on February 07, 2017
• Recall Number: Z-2364-2016
• Recall Event ID: 74581
• 510(K)Number: K914488
• Product Classification: Conserver, oxygen - Product Code NFB
• 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.
• 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.
• Recalling Firm/ Manufacturer: Invacare Corporation; 1 Invacare Way; Elyria OH 44035-4190
• For Additional Information Contact: 877-413-6008
• Manufacturer Reason for Recall: The rear gradation scale was screen printed upside down on the flowmeter gauge.
• FDA Determined Cause: Process control
• Action: lnvacare Corporation sent an Urgent Medical Device Recall letter dated June 27, 2016, to all affected consignees with return receipt to notify them of the recall. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees with questions were instructed to call 877-413-6008.
• Quantity in Commerce: 395
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NFB