Events

Recall of CENTRY SYSTEM DIALYZERS HOLLOW FIBER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION.

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
    14751
  • Event Risk Class
    II
  • Event Initiated Date
    1997-02-20
  • 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

Device

CENTRY SYSTEM DIALYZERS HOLLOW FIBER
  • Model / Serial
    Model Catalog: (Lot serial: LOT # G09B5293); Model Catalog: (Lot serial: CAT. # 003 529 000); Model Catalog: (Lot serial: LOT # G07B5291); Model Catalog: (Lot serial: LOT # G07B5292); Model Catalog: (Lot serial: LOT # G07B5293); Model Catalog: (Lot serial: LOT # G07B5294); Model Catalog: (Lot serial: LOT # G10B5293 G11B5291); Model Catalog: (Lot serial: LOT # G10B5291 G10B5292); Model Catalog: (Lot serial: LOT # G09B5294); Model Catalog: (Lot serial: LOT # G09B5291); Model Catalog: (Lot serial: LOT # G08B5293); Model Catalog: (Lot serial: LOT # G08B5292)
  • Manufacturer
    GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION

Manufacturer

GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION
  • Manufacturer Address
    LAKEWOOD
  • Source
    HC