Events

Recall of Device Recall CT99 Cold Therapy Pad

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cincinnati Sub-Zero Products 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
    70207
  • Event Risk Class
    Class 2
  • Event Number
    Z-1129-2015
  • Event Initiated Date
    2015-01-07
  • Event Date Posted
    2015-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132502
  • 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
    Pack, hot or cold, water circulating - Product Code ILO
  • Reason
    Seals in the water path of the ct-99 cold therapy pad may separate during use, which could lead to a water leak.
  • Action
    Cincinnati Sub-Zero sent an Urgent Medical Device Recall Field Action Notice dated January 7, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use and/or further distribution of the affected product. Customers were instructed to obtain a Return Material Authorization Number and return the pad(s) for exchange. Customers with questions were instructed to call 1-800-989-7373 or 513-772-8810. Customers were also asked to commplete and return the enclosed Response Form as soon as possible by fax to (513)772-9119 to acknowledge receipt of the notification and to inform CSZ that they have performed the requested actions. For questions regarding this recall call 513-772-8810, ext 6816

Device

Device Recall CT99 Cold Therapy Pad
  • Model / Serial
    Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.
  • Product Description
    Cold Therapy Pad - cold water circulating pad, one unit per package. || The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Manufacturer Address
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA