Events

Recall of Device Recall Rubicor

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

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
    34859
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-06
  • Event Initiated Date
    2006-02-17
  • Event Date Posted
    2006-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44835
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Devices' sterility may be compromised due to lack of adequate sterilization.
  • Action
    On 2/17/06, the firm initiated the recall and its notification was via sales rep retrieval and follow-up letter dated 3/13/06 explaining the reason for the recall and requesting the product be returned.

Device

Device Recall Rubicor
  • Model / Serial
    Lot number: 06011817
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. The product was released for distribution to 19 consignees in US. The firm''s sales force were able to retrieve 18 units, only one (1) was used by a consignee. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, physicians who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, || Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
  • Manufacturer
    Rubicor Medical

Manufacturer

Rubicor Medical
  • Manufacturer Address
    Rubicor Medical, 600 Chesapeake Drive, Redwood City CA 94063-1712
  • Source
    USFDA