Events

Rappel de Xenon Diagnostic Circuit Kits

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 Continental Medical Labs,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
    55527
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1754-2010
  • Date de mise en oeuvre de l'événement
    2010-04-16
  • Date de publication de l'événement
    2010-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91038
  • 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
    filter, bacterial, breathing-circuit - Product Code CAH
  • Cause
    Cml, inc. was notified by a-m systems in a letter dated march 31, 2010 that they were recalling a component of their xenon kit (viromax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together.
  • Action
    The firm, A-M Systems, sent two "URGENT: Notification of Product Recall/Correction" letters one dated March 31, 2010 and the other dated April 7, 2010 to customers. The letters described the product, problem and action to be taken by customers. Also enclosed was a list of the affected products that was sold to the consignee. The customer was instructed to cease further distribution or use of any remaining products from the listed lots, immediately notify any customers who received products from the lots, provide A-M Systems with the number of items distributed and still remaining in their inventory, once the number is provided the customer should destroy or discard any remaining product in their possession from these lot numbers. Please feel free to contact Robert Thompson by phone 360-683-8300 x302 or email: rthompson@a-msystems.com with any questions, comments or concerns.

Device

Xenon Diagnostic Circuit Kits
  • Modèle / numéro de série
    Lot #'s for RAF Medical, Inc.:  1002092, 1001211, 1002011, 1002192, 1003081, 1003231, 1002012, 1003085, 1001263, 1003186,1004051, 1002112, 1003086, 1003082, 1003245, 1003291, 1002081, 1002111, 1001222, 1002193, 1003083, 1003241, 1002013, 1003084, 1003242, 1001181, 1003296,   Lot #'s for Medico-Mart: 10020414, 1002191, 1003088
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: WI
  • Description du dispositif
    Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 || RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). || Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
  • Manufacturer
    Continental Medical Labs,Inc

Manufacturer

Continental Medical Labs,Inc
  • Adresse du fabricant
    Continental Medical Labs,Inc, 813 Ela Ave / PO Box 306, Waterford WI 53185-0306
  • Société-mère du fabricant (2017)
    Continental Medical Labs, Inc
  • Source
    USFDA