Events

Rappel de Device Recall External Sterilizable Paddles

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 Physio Control, 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
    50214
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2311-2010
  • Date de mise en oeuvre de l'événement
    2008-11-17
  • Date de publication de l'événement
    2010-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74992
  • 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
    Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
  • Cause
    Sterilization efficacy could not be confirmed for sterilization methods on external sterilizable paddles and pediatric paddle attachments.
  • Action
    On 11/14/08, Physio Control began sending the Urgent User Information letter via certified mail to their customers. The letter notified the customers about the modification to the cleaning and sterilization instruction of the External Sterilization Defibrillation Paddles and Pediatric Paddle attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitors The customers are informed to discontinue use of the gas sterilization methods listed as 12/88 Ethylene Oxide (EO) or 100% Ethylene Oxide (OE). They are notified that they can continue to use the sterilization method such as STERRAD per existing Operating Instructions, but limit sterilization cycles from 100 to 50 cycles. The customers are advised that prior to and after each use, they should examine cables and connector for damage or signs of wear such as loose connections, damaged pins, exposed wires and cable connector corrosion and examine paddles for scratched or pitted surfaces and stop using product if damage has occurred. Within 45 days, the firm will update the Operating Instruction that will include revised Sterilization Guidelines on a website www.physio-control.com/products/product-support. Customers can call Technical Support at 1-800-442-1142, #5 or they can visit the firm's website at www.physio-control-notices.com/extpaddles regarding the recall.

Device

Device Recall External Sterilizable Paddles
  • Modèle / numéro de série
    The product does not have serial numbers or lot numbers.   External Sterilizable Paddles used with LIFEPAK 12 and 20/20e Defibrillators have a Part Number 3009166-XX (XX symbolized any 2 numbers).   External Sterilizable Paddles used with LIFEPAK 9 and 9P Defibrillators have a Part Number 804507-XX (XX symbolizes any 2 numbers).
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Devices were distributed to medical facilities through out the US and WORLD WIDE to Canada, Germany, India, Netherlands, Australia, Hong Kong, Japan, Brazil, Panama, Russia, Korea, Malaysia, Venezuela, and United Arab Emirates(UAE) .
  • Description du dispositif
    External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Adresse du fabricant
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA