Events

Recall of Device Recall Stryker Irrigator Reusable Tips

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
    64682
  • Event Risk Class
    Class 2
  • Event Number
    Z-1232-2013
  • Event Initiated Date
    2013-03-27
  • Event Date Posted
    2013-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116786
  • 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
    The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
  • Action
    Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall Stryker Irrigator Reusable Tips
  • Model / Serial
    Manufacturer Part Number: 250-070-487
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
  • Product Description
    Stryker Irrigator Reusable Tips: || 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. || Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA