Events

Recall of Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ATS 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
    35745
  • Event Risk Class
    Class 3
  • Event Number
    Z-0079-2007
  • Event Initiated Date
    2006-05-05
  • Event Date Posted
    2006-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46717
  • 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
    Cryo surgical clamp - Product Code GEH
  • Reason
    Incorrect expiration date: three lots of the frostbyte (tm) clamp packaged with surgifrost 7 cm cryosurgical probes have incorrect expiration dates. these lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.
  • Action
    Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.

Device

Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clamp
  • Model / Serial
    Lot: 50515, 50602, 50609
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide-ATS Medical distirubted devices to hospitals located in the following states IN, KS, MO, TX. There may be other US distributors of this product.
  • Product Description
    CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.
  • Manufacturer
    ATS Medical, Inc.

Manufacturer

ATS Medical, Inc.
  • Manufacturer Address
    ATS Medical, Inc., 3905 Annapolis Ln N Ste 105, Minneapolis MN 55447-5473
  • Source
    USFDA