Events

Rappel de Gravity and Infusion Pump Intravenous (IV) Sets using the Ysite Ultrasite Valve

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 Braun,B Medical Inc.

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
    26226
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0933-03
  • Date de mise en oeuvre de l'événement
    2003-04-14
  • Date de publication de l'événement
    2003-06-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27312
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Cause
    Possible leakage.
  • Action
    The recalling firm sent recall letters to their direct accounts dated 4/14/03. The recall letters inform the accounts of the problem and the need to return the product.

Device

Gravity and Infusion Pump Intravenous (IV) Sets using the Ysite Ultrasite Valve
  • Modèle / numéro de série
    Catalog #352004 - Lot #s 0060390643, 0060390644, 0060395269, 60395272, 60429525, 0060411651, 0060426960, 0060429525, and 0060430054. Catalog #352049 - Lot #s 0060381759, 0060384115, 0060386555, 0060388678, 0060391072, 0060392950, 0060397344, 0060399612, 0060405055, 0060406467, 0060408425, 0060410255, 0060411638, 0060412823, 0060419500, 0060421552, 0060426399, 0060429531, 0060430749, 0060435319, 0060437596, and 0060437913. Catalog #352051 - Lot #s 0060419038 and 0060419039. Catalog #352222 - Lot #s 0060381626, 0060386862, 0060390599, 0060393331, 0060397325, 0060411966, 0060417244, 0060420643, and 0060429830. Catalog #352223 - Lot #s 0060395209, 0060420353, and 0060432419.  Catalog #352224 - Lot # 0060374720 Catalog #352225 - Lot #s 0060406237, 0060411540, and 0060417245. Catalog #352237 - Lot #s0060386868, 0060384090, 0060397352, 006042859, 0060435289 and 0060393337. Catalog #352238 - Lot #s 0060379443, 0060413601, 0060419352 and 0060397391. Catalog #352340 - Lot # 0060399651 Catalog #352341 - Lot #0060419800 Catalog #352342 - Lot #s 0060385368 and 0060386187 Catalog #352355 - Lot #s 0060381731, 0060386533, 0060405539, and 0060421540. Catalog #352356 - Lot #s 0060384095, 0060405753, 0060412569, 0060419498, and 0060428603. Catalog #352362 - Lot # 0060390627 Catalog #352379 - Lot #s 0060386755 and 0060390530 Catalog #352393 - Lot #s 0060379061, 0060386808, 0060390531, 0060395158, 0060397119, and 0060417162. Catalog #352396 - Lot #s 0060379062, 0060385889, 0060390534, 0060397122, and 0060408823. Catalog #352406 - Lot #s 0060388274, 0060395165, 0060397235, 0060408828, 0060411870, and 0060420593. Catalog #352409 - Lot # 0060388275 Catalog #352413 - Lot #s 0060397890, 0060409013, 0060411626, and 0060411975. Catalog #352420 - Lot #s 0060406524, 0060412700, 0060421691, 0060432013, 0060432988, and 0060433472. Catalog #352421 - Lot #s 0060404049, and 0060411708. Catalog #352422 - Lot #s 0060404062, 006040908, and 0060417538. Catalog #352423 - Lot # 0060404052 Catalog #352444 - Lot # 0060417840 Catalog #352446 - Lot # 0060417838 Catalog #352455 - Lot #0060417841 Catalog #375038 - Lot #s 0060406603 and 0060408468 Catalog #375084 - Lot #s 0060397187 and 0060422174 Catalog #375088 - Lot #s 0060381216, 0060386872, and 0060417250. Catalog #375090 - Lot #s 0060386873, 0060411552, and 0060417251. Catalog #375100 - Lot #s 0060381725, 0060384081, 0060384082, 0060385182, 0060388670, 0060388671, 0060391024, 0060395171, 0060395185, 0060398414, 0060403467, 0060403471, 0060408406, 0060408407, 0060408408, 0060410249, 0060411025, 0060412517, 0060412992, 0060413598, 0060418255, 0060418257, 0060418455, and 0060421541. Catalog #375101 - Lot #s 0060386532, 0060395172, 0060399599, 0060406462, 0060410025, 0060418444, 0060426298, 0060427317, and 0060438111.  Catalog #375105 - Lot #s 0060391170, 0060397412, 0060399667, 0060403501, 0060405234, 0060410306, 0060412697, 0060424455, 0060427890, 0060430736, and 0060432994. Catalog #375135 - Lot # 0060393350 Catalog #375151 - Lot #s 0060399411, 0060408845, and 0060424446. Catalog #375155 - Lot #s 0060408847 and 0060419024. Catalog #472033 - Lot #s 0060373796, 0060373797, 0060373800, 0060378892, 0060378893, and 0060378894. Catalog #473436 - Lot #s 0060385366, 0060386542, 0060395227, 0060423199, 0060424318, 0060425256, 0060425671, 0060428044, and 0060432415. Catalog #473992 - Lot # 0060432401 Catalog #474516 - Lot # 0060401098 Catalog #474577 - Lot #s 0060381183, 0060382531, 0060388314, and 0060411522. Catalog #474912 - Lot #s 0060398364 and 0060417227. Catalog #CC1260-SP02 - Lot #s 0060428236, 0060432935, 0060438115, and 0060432936. Catalog #S5403001N - Lot #s 0060378529, 0060380587, 0060387639, 0060392813, and0060407453. Catalog #S9903301N - Lot # 0060418246 Catalog #US1380 - Lot #s 0060391069 and 0060403474. Catalog #US3115 - Lot #s0060387950, 0060388508, 0060406192, 0060410297, 0060419358, 0060419972, 0060426441, and 0060428624. Catalog #US3116 - Lot # 0060410763 Catalog #US3120 - Lot #s 0060386610, 0060397408, 0060406515, 0060410310, 0060413656, 0060424458, 0060427887, and0060435342. Catalog #US3130 - Lot #s 0060381801, 0060384195, 0060386619, 0060386621, 0060386792, 0060387920, 0060387921, 0060388758, 0060390219, 0060391167, 0060391168, 0060393010, 0060395363, 0060395364, 0060395373, 0060397407, 0060398938, 0060403494, 0060403495, 60405210, 60408590, 0060406071, 0060408480, 0060408485, 0060408590, 0060412691, 0060412692, 0060413650, 0060413651, 0060417595, 0060418182, 0060419378, 0060419381, 0060419384, 0060421685, 0060421687, 0060423935, 0060424451, 0060424452, 0060424453, 0060424459, 0060424460, 0060424699, 0060425148, 0060426360, 0060426361, 0060427884, 0060427885, 006040058, 0060430943, 0060430944, 0060430945, 0060435339, 0060435816, 0060437605, 0060437607, and 0060437609. Catalog #US3131 - Lot #s 0060385347, 0060385365, and 0060386180. Catalog #US3169 - Lot #s 0060397410 and 0060413655. Catalog #US3485 - Lot #s 0060384044, 0060397229, 0060408385, 0060410245, 0060413662, 0060420137, 0060421697, 0060432014, and 0060435399. Catalog #US3488 - Lot #s 0060386525 and 0060412568. Catalog #US5300 -Lot #s S-0776, S-0777, S-0778, S-0903, 30049, 30096, 30149, and 30150. Catalog #US6413 - Lot #s 0060381721, 0060397240, 0060403462, 0060411045, 0060411635, 0060412564, 0060418436, and 0060432400. Catalog #US6415 - Lot #s 0060386526 and 0060412567. Catalog #V5534-SP02 - Lot #s 0060405704 and 0060417228.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The products were shipped to medical facilities and distributors nationwide. The products were also shipped to the firm''s German facility, Canada and Spain.
  • Description du dispositif
    Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.
  • Manufacturer
    Braun,B Medical Inc

Manufacturer

Braun,B Medical Inc
  • Adresse du fabricant
    Braun,B Medical Inc, 901 Marcon Blvd, Allentown PA 18103
  • Source
    USFDA