Events

Recall of Device Recall Stryker SmartPump Extension Tubing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    59791
  • Event Risk Class
    Class 3
  • Event Number
    Z-3274-2011
  • Event Initiated Date
    2011-08-25
  • Event Date Posted
    2011-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103747
  • 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
    Accessories for Pneumatic Tourniquet - Product Code KCY
  • Reason
    Three complaints have been reported indicating that the product inside the package did not match the label description. the units had quick connectors instead of luer lock connectors as stated in the label description.
  • Action
    Stryker Instruments sent out "Urgent Medical Device Recall" notices dated August 22, 2011 to all affected customers. The letter included the name of the recalled product, lot numbers, and the reason for the recall. Customers were instructed to send back any product to Stryker that is within the affected lots. The letter further stated Stryker will quarantine the product and replace any product that is returned. For information on this recall contact Stryker Instruments at (269) 389-4534.

Device

Device Recall Stryker SmartPump Extension Tubing
  • Model / Serial
    60" Part number 5920-000-003; lot number 11137012. 40" Part number 5920-000-005; lot number 11138012.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE
  • Product Description
    Stryker SmartPump Extension Tubing (Pneumatic tourniquet). || Sterile tubing extension 40" and 60", set, luer lock. Rx only. || Stryker Instruments Div. of Stryker Corporation. || Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA