Events

Recall of Device Recall Color Cuff II, Double Port Single Bladder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ascent Healthcare Solutions, 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
    47343
  • Event Risk Class
    Class 2
  • Event Number
    Z-1678-2008
  • Event Initiated Date
    2008-03-11
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69266
  • 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
    Pneumatic tourniquet - Product Code KCY
  • Reason
    Sterility compromised -- ascent healthcare solutions cannot validate the sterilization process for a variety of ascent healthcare solutions products.
  • Action
    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com.

Device

Device Recall Color Cuff II, Double Port Single Bladder
  • Model / Serial
    Catalog No DT-7034-02-QC, Lot No 135905.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution.
  • Product Description
    Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet.
  • Manufacturer
    Ascent Healthcare Solutions, Inc.

Manufacturer

Ascent Healthcare Solutions, Inc.
  • Manufacturer Address
    Ascent Healthcare Solutions, Inc., 5307 Great Oak Drive, Lakeland FL 33815-3113
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA