Recall of Device Recall lnvacare Precise Rx Pediatric Flowmeter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74581
  • Event Risk Class
    Class 2
  • Event Number
    Z-2364-2016
  • Event Initiated Date
    2016-06-21
  • Event Date Posted
    2016-08-08
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-02-07
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Conserver, oxygen - Product Code NFB
  • Reason
    The rear gradation scale was screen printed upside down on the flowmeter gauge.
  • 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.

Device

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
  • Source
    USFDA