Events

Recall of Device Recall Cruciform Slit Valve

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

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
    28392
  • Event Risk Class
    Class 3
  • Event Number
    Z-0585-04
  • Event Initiated Date
    2004-01-06
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31752
  • 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
    Shunt, Central Nervous System And Components - Product Code JXG
  • Reason
    Mislabeled - product actually single valve.
  • Action
    The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.

Device

Device Recall Cruciform Slit Valve
  • Model / Serial
    UbaV/V020/07-2003
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to two hospitals - one in CA and one in AZ.
  • Product Description
    Cruciform Slit Valve
  • Manufacturer
    Phoenix Biomedical

Manufacturer

Phoenix Biomedical
  • Manufacturer Address
    Phoenix Biomedical, 2495 General Armistead Ave, Norristown PA 19403
  • Source
    USFDA