Events

Recall of Reusable Catheter Passer

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

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
    27416
  • Event Risk Class
    Class 2
  • Event Number
    Z-0160-04
  • Event Initiated Date
    2003-09-09
  • Event Date Posted
    2003-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29842
  • 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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
  • Reason
    Mislabeled as sterile.
  • Action
    The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.

Device

Reusable Catheter Passer
  • Model / Serial
    Catalog number SP01, Lot numbers H0359, J0107, and J0493.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to one distributor in NY and two hospitals in TX and UT. The products were also shipped to distributors in Holland, Greece, Austria, Norway, Taiwan, and Finland.
  • Product Description
    Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
  • Manufacturer
    Vygon US LLC

Manufacturer

Vygon US LLC
  • Manufacturer Address
    Vygon US LLC, 2495 General Armstead Ave, Norristown PA 19403
  • Source
    USFDA