Events

Recall of Device Recall Fisherbrand

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
    67786
  • Event Risk Class
    Class 2
  • Event Number
    Z-1521-2014
  • Event Initiated Date
    2014-02-05
  • Event Date Posted
    2014-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126325
  • 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
    A customer reported the presence of an organism in a lot of calcium alginate fiber tipped wood applicator swab.
  • Action
    Fisher Scientific sent an Urgent: Medical Device Recall/Return letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE USER OR DISTRIBUTOR: Fisher Scientific requests that you discontinue use and distribution of all products referenced above. We also request that you return all product (opened and unopened) as soon as possible. A credit will be issued for returned product. User: Fisher Scientific requests that you complete the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned product(s) in your inventory, within three (3) working days. Distributor: Our records indicate that you may have purchased one or more of the above products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. Fisher Scientific requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned catalog numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base to advise them of the expanded recall, by providing them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgment Form and request that your customer return the Acknowledgment Form to you, and you notify us of the information conveyed in such Acknowledgment Form(s). ACTION BY FISHER SCIENTIFIC: Fisher Scientific has no inventory of the affected products as it was discontinued in May 2013. However, we do have alternative products that we can recommend as replacements. Please contact customer service for information on product alternatives. We appreciate your immediate attention to this expanded voluntary recall. By returning the attached Acknowledgment Form you wil

Device

Device Recall Fisherbrand
  • Model / Serial
    all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack || Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack || Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack || culture collection and industrial surfaces
  • 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