Events

Recall of Device Recall CSA Medical trufreeze

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CSA 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
    69806
  • Event Risk Class
    Class 2
  • Event Number
    Z-0941-2015
  • Event Initiated Date
    2014-11-10
  • Event Date Posted
    2015-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131570
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Reason
    An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
  • Action
    The firm, CSA Medical, sent a letter to its consignees 11/14/2014, via Fedex overnight . The letter explains the event and asks consignees to us a verbal call of time during the cryogen spray period until the root cause is determined and a permanent correction is implemented. Consignees are also asked to complete an acknowledgment form and return it to CSA Medical via, fax, email, telephone, etc.

Device

Device Recall CSA Medical trufreeze
  • Model / Serial
    Console SN/Lot NO: 01-00109, 01-00112, 01-00113, 01-00115, 01-00120, 01-00121, 01-00122, 01-00123, 01-00132, 01-00133, 01-00135, 01-00137, 01-00142, 01-00148, 01-00156, 01-00159, 01-00160, 01-00161, 01-00162,  01-00163, 01-00165, 01-00166, 01-00168, 01-00169, 01-00170, 01-00171, 01-00172, 01-00173, 01-00174, 01-00175, 01-00176, 01-00177, 01-00178, 01-00179, 01-00180, 01-00181, 01-00182, 01-00183, 01-00185, 01-00186,  01-00187, 01-00188, 01-00189, 01-00190, 01-00191, 01-00192
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV.
  • Product Description
    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device || ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** || The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
  • Manufacturer
    CSA Medical

Manufacturer

CSA Medical
  • Manufacturer Address
    CSA Medical, 91 Hartwell Ave, Lexington MA 02421-3137
  • Manufacturer Parent Company (2017)
    CSA Medical Inc.
  • Source
    USFDA