Events

Recall of Device Recall Stryker

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
    35610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1177-06
  • Event Initiated Date
    2006-06-02
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46467
  • 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
    Laparoscope, Gynecologic (And Accessories) - Product Code HET
  • Reason
    Device for which sterility may be compromised as evidenced by a loss of package integrity.
  • Action
    On 6/2/06, 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 Stryker
  • Model / Serial
    Lots 04051142--06121FE2, 04051142--06123FE2
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, || Model Numbers: || 620-030-201, || 620-030-301
  • Manufacturer
    Stryker Endoscopy

Manufacturer

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