Events

Recall of Device Recall SafeSheath

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

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
    29395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1086-04
  • Event Initiated Date
    2004-06-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33664
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
  • Action
    The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.

Device

Device Recall SafeSheath
  • Model / Serial
    All lot numbers are affected.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.
  • Product Description
    SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • Manufacturer Address
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA