Events

Recall of vanSonnenberg Sump

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

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
    36136
  • Event Risk Class
    Class 2
  • Event Number
    Z-1499-06
  • Event Initiated Date
    2006-08-10
  • Event Date Posted
    2006-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48060
  • 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
    drain - Product Code GBW
  • Reason
    Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
  • Action
    Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.

Device

vanSonnenberg Sump
  • Model / Serial
    Lot 8606405; exp. March 31, 2009.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Texas.
  • Product Description
    Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA