Events

Rappel de 3M Universal Electrosurgical Pad

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 - Health Care Business.

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
    75644
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0701-2017
  • Date de mise en oeuvre de l'événement
    2016-10-26
  • Date de publication de l'événement
    2016-12-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150979
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    3m is recalling universal electrosurgical pads because a report of an unintended material (process liner) in the product. this may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.
  • Action
    3M sent an Urgent Medical Device Recall letter dated October 26, 2016 to affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to complete and return the attached Customer Product Return and Recall Form. Customers with questions can contact 3M Health Care Customer Helpline at 1-800-228-3957, 8:30 am - 7:00 pm EST.

Device

3M Universal Electrosurgical Pad
  • Modèle / numéro de série
    Product REF 9130 Lot Numbers: 2019-02DT (Expiration 02-2019) and 2019-03DU (Expiration 03-2019) Product REF 9735-LP Lot Numbers: 2019-02DB and 2019-02CY. (Both with Expiration 02-2019)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa.
  • Description du dispositif
    3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and || 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) || Product Usage: || 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY, etc.). 3M Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended application could lead to an unsafe condition.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Adresse du fabricant
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA