Events

Rappel de Device Recall PenAdapt"(PenAdapt is a TM of Buffalo Filter)

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 Stryker Instruments Div. of Stryker 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
    67746
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1493-2014
  • Date de mise en oeuvre de l'événement
    2014-03-26
  • Date de publication de l'événement
    2014-04-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126202
  • 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
    Apparatus, exhaust, surgical - Product Code FYD
  • Cause
    During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the.
  • Action
    On March 26, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL NOTIFICATION to their consignees via mail and email. Notification included product description, reason for recall, risk to health, and actions to be taken by the Customer/User. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Angela Ragainis/Kelly Jo Whipple 269-389-4354 / 269-389-2921 angela.ragainis@stryker.com / kellyjo.whipple@stryker.com Customers will be asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers will return affected product to Stericycle for destruction using a return label provided by Stryker or Stericycle. Upon receipt of affected product a credit will be issued to customer account. In addition, facilities are being asked to research their records for patient issues that may have been associated with the use of a recalled device, such as infection and/or inflammation.

Device

Device Recall PenAdapt"(PenAdapt is a TM of Buffalo Filter)
  • Modèle / numéro de série
    Part Number 0702-045-027
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
  • Description du dispositif
    Stryker PenAdapt"; Rx Only, Sterile. || This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA