Events

Rappel de CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds

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 Invacare Corporation.

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
    56336
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2402-2010
  • Date de mise en oeuvre de l'événement
    2007-10-11
  • Date de publication de l'événement
    2010-09-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93266
  • 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
    Cover, Mattress (Medical Purposes) - Product Code FMW
  • Cause
    In october 2007 invacare corporation, florida recalled careguard mattresses, models cg10180 and cg10180a, associated with ivc bed series full electric beds, semi-electric beds and manual beds and the valuecare bed series semi electric beds, when used with invacare bed rails. affected bed packages are bed24ivc, bed25ivc, bed24ca, and bed25ca. the mattresses when used in combination with the ivc a.
  • Action
    Consignees were notified of the recall by letter dated October 15, 2007 and entitled "CareGuard Mattresses Provided Since September 2006 In combination with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds, and the Value Care Bed Series Semi Electric Bed, and Full and Half-Length Rails". Depending on the mattress usage the consignees were instructed to either: A: 1) Move the bed rail cross bar from the 5th and 6th spring location on the head section of the bed to the 6th and 7th spring location on the head section of the bed in accordance with the enclosed instructions and document your actions on the enclosed tracking sheet. 2) Return of the Product Tracking Report indicating disposition of the recalled product and acknowledgement of receipt of the recall package. 3) The tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credit. or B) 1) contact Customer Service and request part No. 6022, which is a kit that contains a 2" convoluted foam pad, warning label and installation instructions. Testing has shown that the addition of the foam pad on a new mattress with Invacare half rails / bed combination meets the Guidance requirements." 2) When you have completed placing the label and foam topper on all of your affected mattresses, return the tracking sheet to us and we will credit your account $10 for each mattress you have listed. the tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credi

Device

CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds
  • Modèle / numéro de série
    September 2006 through July 2007.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. || Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). || Manufactured by: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. || Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 2101 E. Lake Mary Blvd., Sanford FL 32773
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA