Events

Recall of Pilling CenterAction Forceps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Telefelx Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0266-2008
  • Event Initiated Date
    2007-10-31
  • Event Date Posted
    2007-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65715
  • Notes / Alerts
    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.
  • Extra notes in the data
    Forceps - Product Code HTD
  • Reason
    The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.
  • Action
    Consignees were notified by an Urgent Medical Device Recall letter on/about 11/1/2007. They were instructed to immediately cease use and distribution of the affected product and to return them to Teleflex Medical, Durham, NC. In addition, each were instructed to forward the letter if they had further distribution into institutional settings or to homecare patients and retrieve relevant product form those locations. An Acknowledgement & Stock Status Form was enclosed to be completed and faxed back to Teleflex Medical.

Device

Pilling CenterAction Forceps
  • Model / Serial
    Date Codes: WW5, XX5, NN6, RR6, TT6, XX6, MM7, NN7, OO7, QQ7 and SS7
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, NV, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, France New Zealand and Singapore.
  • Product Description
    Pilling¿ Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Manufactured for : Teleflex Medical, Research Triangle Park, NC 27709 USA
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Manufacturer Address
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA