Events

Recall of Device Recall 27023WU Balloon Catheter

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

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
    65505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1728-2013
  • Event Initiated Date
    2013-05-31
  • Event Date Posted
    2013-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119378
  • 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
    Catheter, balloon type - Product Code GBA
  • Reason
    Karl storz endoscopy-america has initiated the recall of the 27023wu balloon catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
  • Action
    The firm, Karl Storz, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated May 31, 2013 to all customers who purchased the 27023WU Balloon Catheter. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and to return the recalled product back to Karl Storz.. The customers were also instructed to complete and fax back the Recall Response Form attached with the safety alert letter at Fax #424-218-8559. If you have any questions, please feel free to call 424-218-8289.

Device

Device Recall 27023WU Balloon Catheter
  • Model / Serial
    Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to: AZ, FL, IL, IN and TX.
  • Product Description
    27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. || The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 15 Wells St, Southbridge MA 01550-4503
  • Manufacturer Parent Company (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA