Events

Recall of Replacement Gastrostomy Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C R Bard 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
    49523
  • Event Risk Class
    Class 2
  • Event Number
    Z-0416-2009
  • Event Initiated Date
    2008-09-23
  • Event Date Posted
    2008-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73722
  • 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
    Gastrointestinal Tube (and accessories) - Product Code KNT
  • Reason
    Gastrostomy device anti-reflux valve may allow leakage from the stomach.
  • Action
    Customers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689.

Device

Replacement Gastrostomy Device
  • Model / Serial
    43AOA018, 43AOA041, 43APA032, 43BOA015, 43BOA037, 43BPA025,  43BQA042, 43BQA184, 43COA013, 43COA036, 43CQA232, 43DOA010,  43DOA037, 43DPAO14, 43DQA063, 43EOA0 13, 43EOA041, 43EPAO13, 43EPA040, 43FOA076, 43FOA107, 43FOA234, 43GOA033, 43GOA009,  43GPA177R, 43GPA178R, 43GPA190R, 43GPA195R, 43HOA031,  43HPA018, 43HPA050, 43HPA223R, 43INA031, 43IOA038, 43IPA017R,  43IPA207R, 43IQA001, 43JNAOO1, 43JNAO44, 43JNA203, 43JNA219,  43JOA014, 43JPA013, 43JPA036, 43KNA012, 43KNA053, 43KOA016,  43KPA013, 43LNAO22, 43LNAO52, 43LOA023, 43LQA001, HURB2525,  HURB3526, HURD1915, HURF0483, HURG1443, HURH1078,  HURJ0571, HURB2422, HURD0734, HURE0535, HURE2889, HURG1444,  and HURJ0594.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.
  • Product Description
    Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. || Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. || The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc
  • Manufacturer Address
    C R Bard Inc, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA