Events

Recall of Device Recall Wallach Cryotip

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wallach Surgical Devices, 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
    38072
  • Event Risk Class
    Class 2
  • Event Number
    Z-1046-2007
  • Event Initiated Date
    2007-06-06
  • Event Date Posted
    2007-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52897
  • 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
    Cryosurgical instrument - Product Code GEH
  • Reason
    The tip may separate from the probe.
  • Action
    Wallach Surgical notified accounts by fax on 6/6/07. A follw-up telephone call will be made to the 70 domestic consignees. Foreign consignees notiifed by fax or email with follow-up telephone calls. Accounts are requested to return product and replace with an alternate product.

Device

Device Recall Wallach Cryotip
  • Model / Serial
    All lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania
  • Product Description
    Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X || Reference: 900220
  • Manufacturer
    Wallach Surgical Devices, Inc.

Manufacturer

Wallach Surgical Devices, Inc.
  • Manufacturer Address
    Wallach Surgical Devices, Inc., 235 Edison Road, Orange CT 06477-3603
  • Source
    USFDA