Events

Recall of Device Recall Fisherbrand Sterile Swabs

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

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
    65822
  • Event Risk Class
    Class 2
  • Event Number
    Z-1955-2013
  • Event Initiated Date
    2013-06-05
  • Event Date Posted
    2013-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120307
  • 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
    Applicator, absorbent tipped, sterile - Product Code KXG
  • Reason
    The firm is recalling fisherbrand sterile swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. the finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
  • Action
    Customers were notified by letter on June 18, 2013 and requested to discontinue use and return all affected product. The firm also asked that any additional affected customer base be contacted and notified of the recall if the lots had been further distributed. If you have any questions, contact Stericycle (reference "Event 4070") at 1-877-410-5558.

Device

Device Recall Fisherbrand Sterile Swabs
  • Model / Serial
    Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and the country of Canada.
  • Product Description
    Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. || Used in applying medications to or take specimens from a patient.
  • Manufacturer
    Fisher Scientific Co

Manufacturer

Fisher Scientific Co
  • Manufacturer Address
    Fisher Scientific Co, 300 Industry Dr, Pittsburgh PA 15275-1001
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA