Events

Recall of Device Recall Aspira Peritoneal Drainage system

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

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
    59119
  • Event Risk Class
    Class 3
  • Event Number
    Z-2959-2011
  • Event Initiated Date
    2011-05-21
  • Event Date Posted
    2011-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101264
  • 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, peritoneal, long-term indwelling - Product Code FJS
  • Reason
    Labeling for drainage kit contained incomplete information.
  • Action
    The firm, BARD, sent a letter entitled "Labeling Discrepancy on Aspira Drainage Accessory Kits" dated June 12, 2011 to its customers. The letter provides the customers with the information missing from the labeling and/or IFU stating that the product can be safely used for peritoneal and pleural applications. If you have any questions please do not hesitate to contact BARD at 1-800-290-1689. If there are any clinical questions please contact Medical Services and Support at 1-866-893-2691.

Device

Device Recall Aspira Peritoneal Drainage system
  • Model / Serial
    REUB0097, REUC0050, REUC0344, REUD0610, REUF0562, REUF0720, REUG1336, REUG1398, REUH1217, REUI0188, REUI0189, REUI1235, REUJ0357, REUJ0828, REUJ 0949, REUJ1275, REUK0657, REUK1351, REUL0589, REVA0241, REVA0884, REVB0093, REVB0619, REVC0073, REVC0419.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution.
  • Product Description
    Bard Aspira Dressing Kit, Product Code 4991503. || The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Manufacturer Address
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA