Events

Recall of Device Recall Pilling(R) Coronary Scissors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex 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
    51300
  • Event Risk Class
    Class 2
  • Event Number
    Z-1178-2009
  • Event Initiated Date
    2009-03-03
  • Event Date Posted
    2009-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79686
  • 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
    Surgical Scissors - Product Code LRW
  • Reason
    The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
  • Action
    Consignees were notified by an Urgent Medical Device Recall letter, dated 03/03/2009, via UPS Next Day. Hospitals were instructed to immediately discontinue use of the products, inspect the scissors for the date codes and to return the product to Teleflex Medical for replacement. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be completed and faxed back to Teleflex Medical. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected product retrieved by Teleflex Medical will be destroyed and replacement product provided to the consignee. Records of destruction will be maintained.

Device

Device Recall Pilling(R) Coronary Scissors
  • Model / Serial
    Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of AL, AZ, CA, CO, DC, DE, FL, IA, IN, KS, MA, MD, MI, MO, MS, NH, NJ, NY, NV, OH, OK, OR, PA, RI, TN, TX, UT, and WA, and countries of Australia, Canada, France, Germany, India, Japan, and Singapore.
  • Product Description
    Pilling(R) Coronary Scissors, 120Deg w/bar, Catalog numbers: and 352178, Teleflex Medical, Research Triangle Park, NC 27709
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA