Events

Recall of Device Recall ChoICE PT "J" Tip 182 cm guide Wire

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
    25500
  • Event Risk Class
    Class 3
  • Event Number
    Z-0589-03
  • Event Initiated Date
    2002-07-16
  • Event Date Posted
    2003-02-27
  • 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=25932
  • 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
    Wire, Guide, Catheter - Product Code DQX
  • Reason
    Labeled as j tip but may be straight tip.
  • Action
    The firm notified all user/hospital accounts via a 7/16/2002 letter sent via FEDEX along with a response form. Accounts were to return any recalled product.

Device

Device Recall ChoICE PT "J" Tip 182 cm guide Wire
  • Model / Serial
    Pouch codes are:Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration date of 2004-01. The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch 4562262, expiration date 2004-01.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
  • Product Description
    Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies 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