Rappel de Device Recall lnvacare Precise Rx Pediatric Flowmeter

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Invacare Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74581
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2364-2016
  • Date de mise en oeuvre de l'événement
    2016-06-21
  • Date de publication de l'événement
    2016-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2017-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Conserver, oxygen - Product Code NFB
  • Cause
    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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

  • Adresse du fabricant
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Société-mère du fabricant (2017)
  • Source
    USFDA