Events

Recall of SafeSheath KR under the Pressure Products label

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
    30242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0057-05
  • Event Initiated Date
    2004-10-14
  • Event Date Posted
    2004-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35546
  • 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
    Sheaths may fracture if exposed to excess fluorescent light.
  • Action
    The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.

Device

SafeSheath KR under the Pressure Products label
  • Model / Serial
    Lot number F5861 exp. 6/06 and Lot number 6724 exp. 8/06
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to the label owner/distributor in CA.
  • Product Description
    SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units.
  • 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