Events

Recall of Boston Scientific Radial Jaw Biopsy Forceps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Symbiosis 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
    25510
  • Event Risk Class
    Class 3
  • Event Number
    Z-0562-03
  • Event Initiated Date
    2002-09-03
  • Event Date Posted
    2003-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25945
  • 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
  • Reason
    Product does not have the needle component as part of the jaw assembly.
  • Action
    The firm forwarded recall letters and response forms via Federal Express to Risk Managers at hospitals on 9/3/2002. Accounts were asked to return product by first calling 1-800-862-1284.

Device

Boston Scientific Radial Jaw Biopsy Forceps
  • Model / Serial
    The code for the individual pouches is Catalog 1589 and Lot # 0551847, expiration date of 2005-07. The code for the five pack boxes is Catalog No. 1589 and lot number 0551847, expiration date of 2005-07.
  • Distribution
    Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
  • Product Description
    Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box.
  • Manufacturer
    Symbiosis Corp.

Manufacturer

Symbiosis Corp.
  • Manufacturer Address
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA