Events

Rappel de Device Recall 3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring Electrode V2560

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 3M Company / Medical Division.

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
    56488
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2383-2010
  • Date de mise en oeuvre de l'événement
    2010-07-27
  • Date de publication de l'événement
    2010-09-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93771
  • 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
    Electrode, electrocardiograph - Product Code DRX
  • Cause
    The sensing element of the 3m red dot monitoring electrode, catalog # 2560 and novaplus universal monitoring electrode #v2560 may have corrosion. in an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.
  • Action
    3M sent an "Urgent Medical Device Recall" letters and a "Distributor Product Recall Form" dated July 29, 2010 to customers and distributors of the 3M and Novaplus electrodes. The letters described the 3M Red Dot and Novaplus Universal products, problems and actions to be taken by customers. Customers were instructed to examine their inventory and quarantine the affected lots pending return to the firm. After completing and returning the enclosed Customer Product Recall Form to 3M, customers will be issued a Return Authorization Number and provided with instructions for return of the affected devices. Distributors were instructed to notify customers to the end user level and have them return affected lots to the distributor for forwarding to 3M, or forward the customer letter to end-users to instruct them on how to contact 3M for recovery of the device. The 3M Customer Helpline can be contacted at: 1-800-228-3957.

Device

Device Recall 3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring ...
  • Modèle / numéro de série
    2560 LOT #'S: 2012-06 CX, 2012-06 CY, 2012-06 CZ, 2012-06 DA, 2012-06 DB, 2012-05 CN, 2012-05 CM, 2012-05 CK, 2012-05 CJ, 2012-05 CI, 2012-05 CH,2012-05 CG, 2012-05 CF, 2012-05 CE, 2012-05 CD, and 2012-05 CC. V2560 NOVATION PRIVATE LABEL LOT: 2012-05 CL.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: States of CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, and WI.
  • Description du dispositif
    3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Adresse du fabricant
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA