Events

Recall of Device Recall Disposable StrykeFlow 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
    68624
  • Event Risk Class
    Class 2
  • Event Number
    Z-2080-2014
  • Event Initiated Date
    2014-06-20
  • Event Date Posted
    2014-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128339
  • 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
    System, irrigation, urological - Product Code LJH
  • Reason
    Internal review found that six lots of disposable strykeflow tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
  • Action
    Stryker sent an Urgent Device Removal letter via certified mail on June 20, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused product, inform individuals within their organization who need to aware of the device removal. Customers with questions were instructed to call 1-800-624-4422. For questions regarding this recall call 408-754-2664.

Device

Device Recall Disposable StrykeFlow Tips
  • Model / Serial
    P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.
  • Product Description
    Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
  • 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