Events

Recall of INLINE VALVE WITH ACCESSORIES AND UNITIZED BACTISEAL CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    34782
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    As stated in the codman programmable valve ifu the virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm h2o. recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm h2o. this may result in a delay in treatment for shunt-related complications.

Device

INLINE VALVE WITH ACCESSORIES AND UNITIZED BACTISEAL CATHETER
  • Model / Serial
    Model Catalog: 82-8803 (Lot serial: ALL LOTS); Model Catalog: 82-8804 (Lot serial: CNLCW4); Model Catalog: 82-8804 (Lot serial: CPBB3H); Model Catalog: 82-8802 (Lot serial: ALL LOTS); Model Catalog: 82-8804 (Lot serial: CNPB1V); Model Catalog: 82-8804 (Lot serial: CNNDH3); Model Catalog: 82-8804 (Lot serial: CNMDM3); Model Catalog: 82-8804 (Lot serial: CPBCR0); Model Catalog: 82-8805 (Lot serial: ALL LOTS); Model Catalog: 82-8801 (Lot serial: ALL LOTS); Model Catalog: 82-8806 (Lot serial: ALL LOTS); Model Catalog: 82-8800 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 82-8807 (Lot serial: ALL LOTS)
  • Product Description
    INLINE VALVE UNIT. BACTISEAL CATHACC.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.