Events

Rappel de TAPSCOPE 550

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 Cardiocommand 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
    58302
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0071-2012
  • Date de mise en oeuvre de l'événement
    2010-10-25
  • Date de publication de l'événement
    2011-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98932
  • 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
    System, esophageal pacing - Product Code LPA
  • Cause
    Cardiocommand, inc. is recalling their tapscope 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ecg.
  • Action
    On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.

Device

TAPSCOPE 550
  • Modèle / numéro de série
    Lot Numbers: 1026504, 1023803, 1022901, 1019007, and 1020106.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.
  • Description du dispositif
    ***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. || ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101. || ***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.
  • Manufacturer
    Cardiocommand Inc.

Manufacturer

Cardiocommand Inc.
  • Adresse du fabricant
    Cardiocommand Inc., 4920 W Cypress St, Suite 110, Tampa FL 33607-3837
  • Société-mère du fabricant (2017)
    Cardiocommand Inc.
  • Source
    USFDA