Events

Recall of Pressure Tourniquet Cuffs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Sustainability Solutions.

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
    75221
  • Event Risk Class
    Class 2
  • Event Number
    Z-0324-2017
  • Event Initiated Date
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149691
  • 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
    Tourniquet, pneumatic - Product Code KCY
  • Reason
    Issue with the process for detection of leaking pressure tourniquet cuffs (ptc). leaking ptc devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during bier block requiring medical intervention.
  • Action
    Stryker Sustainability Solutions sent an Customer Notification letter September 19, 2016. Customers were instructed to discontinue use of the affected products. The letter stated to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices containing expiration dates from May 2016-May 2018 remain in inventory. This form must be completed even if no affected product is found. Use the following reference number as you complete the form: [Ship to Account #] If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to the facility. .Adverse reactions or quality problems experienced with the use of this product may be reported to: o Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 o http://www.stryker.com/productexperience/ o The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Device

Pressure Tourniquet Cuffs
  • Model / Serial
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. distribution nationwide. No foreign distribution
  • Product Description
    Reprocessed Pressure Tourniquet Cuff (PTC) || Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA