Events

Rappel de Device Recall Gish Vision Hollow Fiber Oxygenator with GBS Coating.

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 Gish Biomedical 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
    34215
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0519-06
  • Date de mise en oeuvre de l'événement
    2005-11-28
  • Date de publication de l'événement
    2006-02-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43284
  • 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
    Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
  • Cause
    Gish received four reports of potential leakage. all reports were associated with gbs coating. there was no patient injury reported.
  • Action
    The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. 11/14/2005 The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Customer Service will, at the same time, issue a SORMA for the return of coated oxygenators from the consignee. Sequester the coated oxygenator for return to Gish Biomedical. If the consignees prefer, they can provide a contact name and the number of packages to be picked up and the firm will issue a Federal Express call tag for pick-up at the earliest scheduled time.

Device

Device Recall Gish Vision Hollow Fiber Oxygenator with GBS Coating.
  • Modèle / numéro de série
    313417, 324404, 241506, 192513, 206510, 241506, 255514, 283507, 40501, 88508, 199547, 208500, 213508, 213508A, 231517, 290542, 007515, 328426, 074507, 122554, 174519, 262552, 323419, 007515, 338420, 035504, 047500, 047501, 047502, 067549, 088507, 122555, 151543, 151542, 215501, 231519, 129535, 250502, 255515, 323419, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 313451, 334412, 334412A, 038500, 045550, 053513, 102500, 129525, 160500, 193500, 216501, 252500, 276506, 283512, 241509, 255514, 122554, 047502, 328426, 074507, 125515, 157527, 290519, 199512, 133500, 130500, 241500, 314410, 328426, 213508, 313420, 024509, 004507, 067516, 348414, 101518, 047502, 314409, 323419, 007515, 045557, 059500, 109507, 154510, 046502, 143507, 067518, 101520, 038522, 348418, 038522, 080511, 129527, 206515
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico.
  • Description du dispositif
    The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.
  • Manufacturer
    Gish Biomedical Inc

Manufacturer

Gish Biomedical Inc
  • Adresse du fabricant
    Gish Biomedical Inc, 22942 Arroyo Vis, Rancho Santa Margarita CA 92688-2600
  • Source
    USFDA