Events

Recall of V. Mueller PfisterSchwartz Stone Retriever

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

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
    30330
  • Event Risk Class
    Class 2
  • Event Number
    Z-0179-05
  • Event Initiated Date
    2004-10-27
  • Event Date Posted
    2004-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35669
  • 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
    Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
  • Reason
    The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
  • Action
    Field correction recall by letter dated 10/27/04, nforming the accounts of the mislabeling and providing corrective labels with the correct dimensions to place onto the dispensing box.

Device

V. Mueller PfisterSchwartz Stone Retriever
  • Model / Serial
    product code GU6397, lot number 1041194, exp. 2009/08
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    South Carolina, New York, Missouri, West Virginia, Texas and MIssissippi
  • Product Description
    V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Attn V. Mueller Qa, McGaw Park IL 60085
  • Source
    USFDA