Events

Recall of Device Recall Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport.

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
    34028
  • Event Risk Class
    Class 3
  • Event Number
    Z-0297-06
  • Event Initiated Date
    2005-11-07
  • Event Date Posted
    2005-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42932
  • 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
    Mislabeled as 9.5f actually contains 10.5f.
  • Action
    The recalling firm issued letters to their direct accounts via fax on 11/7/05. Letters to the hospital accounts were mailed via UPS overnight on 11/14/05.

Device

Device Recall Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport.
  • Model / Serial
    Catalog number 808950, Lot number S16143
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to one distributor in CA and the label holder in MA. The products were further distributed to hospitals in CA, CO, IL, KY, MO, MS, NC, NE, NY, OH, PA, SC, and TX.
  • Product Description
    Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.
  • 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