Events

Recall of CONTINUUM MR INFUSION SYSTEM SECONDARY ADMINISTRATION LINE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER MEDICAL CARE 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
    98278
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-19
  • 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
    This tubing exhibits a variation that when used in conjunction with any continuum pump may result in flow rate accuracy performance issues. (ex. under-delivery).

Device

CONTINUUM MR INFUSION SYSTEM SECONDARY ADMINISTRATION LINE
  • Model / Serial
    Model Catalog: 3008301 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 3015156 (Lot serial: 10629775); Model Catalog: 3008299 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 3008301 (Lot serial: >40 SERIAL NUMBER); Model Catalog: MIL 200B (Lot serial: >40 SERIAL NUMBER); Model Catalog: 3008299 (Lot serial: >40 SERIAL NUMBER); Model Catalog: 3015153 (Lot serial: 10405982); Model Catalog: 3015153 (Lot serial: 9985611); Model Catalog: 3015153 (Lot serial: 10629773); Model Catalog: 3015153 (Lot serial: 10168545); Model Catalog: 3015153 (Lot serial: 9985612); Model Catalog: 3015155 (Lot serial: 10064742); Model Catalog: 3015550 (Lot serial: 11287 11112 14460); Model Catalog: 3009135 (Lot serial: 11287 11112 14460); Model Catalog: 3013365 (Lot serial: 14245 11336 15736 11267); Model Catalog: 3015550 (Lot serial: 14245 11336 15736 11267); Model Catalog: 3009135 (Lot serial: 14245 11336 15736 11267); Model Catalog: 3013365 (Lot serial: 156641060510944); Model Catalog: 3015550 (Lot serial: 156641060510944); Mod
  • Product Description
    Continuum MR Inf.System Second MIL 200B
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Manufacturer Address
    INDIANOLA
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC