Events

Recall of Device Recall Centrica

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

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
    26324
  • Event Risk Class
    Class 2
  • Event Number
    Z-0935-03
  • Event Initiated Date
    2003-05-13
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27510
  • 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
    Instrument, Biopsy - Product Code KNW
  • Reason
    Recent 'pre-tests' show that argon gas has the potential to escape from the device during a biopsy procedure.
  • Action
    On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall Centrica
  • Model / Serial
    Lot #: 28090403, 03-0085, 03-0086, C030401
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Sanarus brand Centrica¿ Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
  • Manufacturer
    Sanarus Medical Inc

Manufacturer

Sanarus Medical Inc
  • Manufacturer Address
    Sanarus Medical Inc, 5880 West Las Positas Suite 52, Pleasanton CA 95488
  • Source
    USFDA