Events

Rappel de Device Recall COBE Blood oxygenator

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 Cobe Cardiovascular, 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
    35839
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1425-06
  • Date de mise en oeuvre de l'événement
    2006-06-26
  • Date de publication de l'événement
    2006-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47120
  • 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
    blood oxygenator - Product Code DTZ
  • Cause
    Cooling and rewarming time is extended. efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
  • Action
    Consignees were notified by letter on 06/26/2006.

Device

Device Recall COBE Blood oxygenator
  • Modèle / numéro de série
    Serial numbers: 0609400012, 0609400029, 0611500069, 0611500082, 0612800162, 0614300012, 0614300033, 0610800032, 0612800057, 0613600155, 0611500073, 0614300014, 0612200082, 0612200097, 0613600017, 0611500011, 0612800111, 0611500037, 0613500120, 0615000130, 0610100013, 0610100022, 0610100023, 0611500012, 0611500022, 0611500023, 0611500024, 0611500074, 0613600044, 0611600153, 0614200056, 0610100063, 0612800086, 0615000047, 0615000057, 0612200035, 0610100082, 0611500014, 0613500121, 0614300045, 0612200011, 0613500075, 0613500076, 0615000049, 0611500099, 0613500097, 0613500104, 0614300067, 0612800142, 0612200058, 0615200006, 0612400011, 0611500038, 0612200012, 0614200088, 0612200059, 0614300017, 0611500015, 0615000099, 0612200036, 0610800019, 0615000133, 0612800143, 0615000051, 0612200061, 0615000100, 0613600046, 0614300068, 0612200038, 0613800007, 0614300001, 0610100084, 0614300018, 0612200014, 0612200126, 0612800089, 0615000073, 0612800168, 0610900041, 0613100004, 0610900044, 0612800090, 0613600021, 0610800116, 0612200084, 0615000074, 0612200016, 0612800144, 0611500100, 0612800145, 0611500039, 0612800068, 0612400007, 0614200090, 0609400054, 0610100042, 0611500040, 0613600022, 0610800048, 0610800117, 0612200086, 0613600023, 0609400055, 0611500041, 0612800091, 0615000052, 0609400129, 0610100103, 0610700029, 0608900036, 0608900037, 0615200007, 0612900006, 0610100104, 0613800003, 0614300046, 0609400057, 0609400167, 0611500076, 0609400058, 0613600025, 0615000075, 0612200017, 0610100085, 0610100043, 0611600119, 0610100087, 0614300021, 0609400093, 0612200064, 0610800118, 0614300022, 0609400059, 0611500118, 0610100067, 0610100071, 0613100005, 0613100006, 0608700021, 0610100088, 0612800115, 0612200042, 0612200049, 0612200019, 0614300072.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan
  • Description du dispositif
    Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 067594003, 067602001, 067614005, 067625001, 067634005, 067662002, 067668001, 067682001, 067683003, 067686005, 067694002, 067709001, 067710001, 067714001, 067721002, 067722001, 067735002, 078011601, 078011701, 078014002, 078107009, 078149017, 078183015, 078196012, 078249006, 078280017, 078346013, 078351010, 078399009, 078439012, 078522010, 078534012, 078541004, 078549011, 078574008, 078707005, 078766004, 078892004, 078898003, 078909002, 0789337004, 078959005, 078987001, 078988002, 07896006. COBE Cardiovascular, Inc..
  • Manufacturer
    Cobe Cardiovascular, Inc

Manufacturer

Cobe Cardiovascular, Inc
  • Adresse du fabricant
    Cobe Cardiovascular, Inc, 14401 W 65th Way, Arvada CO 80004-3524
  • Source
    USFDA