Events

Recall of FLEXIFLO PATROL ENTERAL PUMP SET WITH PIERCING PIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BGP PHARMA ULC.

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
    27626
  • Event Risk Class
    III
  • Event Initiated Date
    2007-05-09
  • 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
    A small number of enteral pump sets have a 1-3mm slit in the silicone tubing located between the blue connector and the stretch safe-t valve and could result in the under-delivery of enteral product.

Device

FLEXIFLO PATROL ENTERAL PUMP SET WITH PIERCING PIN
  • Model / Serial
    Model Catalog: 52040 (Lot serial: 45679RY); Model Catalog: 52040 (Lot serial: 4670RY); Model Catalog: 52040 (Lot serial: 46759RY); Model Catalog: 52040 (Lot serial: 46776RY 47799RY 47814RY); Model Catalog: 52040 (Lot serial: 47832RY 47842RY 48854RY); Model Catalog: 52040 (Lot serial: 47825RY)
  • Product Description
    PATROL PUMP SET W/PIERCING PIN
  • Manufacturer
    BGP PHARMA ULC

Manufacturer

BGP PHARMA ULC
  • Manufacturer Address
    ETOBICOKE
  • Source
    HC