Events

Rappel de Banicide Advanced

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 Pascal Co 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
    32900
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1588-05
  • Date de mise en oeuvre de l'événement
    2005-08-09
  • Date de publication de l'événement
    2005-12-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41044
  • 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
    Sterilant, Medical Devices - Product Code MED
  • Cause
    The product, banicide advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.
  • Action
    On August 10, 2005 the firm began notifying consignees via phone and began follow up with notification letters on August 12, 2005. Consignees are being asked to return product. The firm subsequently extended its recall after lots manufactured in June 2005 were tested by FDA and failed the sporicidal testing. The firm identified recipients of the affected product and began to contact them by phone on October 3, 2005. The firm began follow-up notification via mail on October 6, 2005. All customers are requested to respond directly to Pascal regarding disposition of any remaining product.

Device

Banicide Advanced
  • Modèle / numéro de série
    the following 3 codes were recalled initially: (LOT EXP 110305, LOT EXP 110605, LOT EXP 110705) On October 3, 2005 the firm expanded the recall to include all product produced between October 2004 through August 2005. Following are all the recalled lot codes.  100105, 100205, 100305, 100405, 100505, 100605,  110105, 110205, 110305, 110405, 110505, 110605, 110705,  120105, 120205, 120305,  010106, 010206, 010306, 010406, 010506,  020106, 020206, 020306, 020406, 020506, 020606, 020706, 020806,  030106, 030206, 030306, 030406, 030506, 030606, 030706, 030806, 030906, 031006, 031106,  040106, 040206, 040306,  050106, 050206, 050306, 050406,  060106, 060206, 060306, 060406, 060506,  070106, 070206, 070306, 070406,  080106,
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    To dental product distributors nationwide and to 1 dental product distributor in Israel. Also directly to dental offices nationwide.
  • Description du dispositif
    product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''
  • Manufacturer
    Pascal Co Inc

Manufacturer

Pascal Co Inc
  • Adresse du fabricant
    Pascal Co Inc, 2929 N E Northup Way, P.O. Box 1478, Bellevue WA 98004
  • Source
    USFDA