Events

Recall of Device Recall StrykeFlow

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

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
    34112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0279-06
  • Event Initiated Date
    2005-11-18
  • Event Date Posted
    2005-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43142
  • 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
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered - Product Code GCX
  • Reason
    Devices for which sterility may be compromised as evidenced by a crack in the package.
  • Action
    On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Device

Device Recall StrykeFlow
  • Model / Serial
    Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
  • Product Description
    StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; || Model Numbers: || 250-070-500, || 250-070-520, || 250-070-540, || 250-070-600, || 250-070-620; || Product is distributed by Stryker Endoscopy, 5900 Optical Court || San Jose, CA 95138
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138
  • Source
    USFDA