Events

Recall of STANDARD PUMP PACK BIOLINE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    119459
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-31
  • 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
    It has been found that in an extremely small number of cases (0.01%) the blood outlet connector adhesive has not maintained its bonding properties and the connector came loose from the housing.

Device

STANDARD PUMP PACK BIOLINE
  • Model / Serial
    Model Catalog: BEQ-HQV 47900 (Lot serial: ALL LOTS); Model Catalog: BE-HQV46900 (Lot serial: ALL LOTS); Model Catalog: BEQ-HQV 52301 (Lot serial: ALL LOTS); Model Catalog: BEQ-HQV 52302 (Lot serial: ALL LOTS); Model Catalog: BE-PLS 2051 (Lot serial: ALL LOTS); Model Catalog: BO-VKMO 50000 (Lot serial: ALL LOTS); Model Catalog: HMO 51000 (Lot serial: ALL LOTS); Model Catalog: HMO 70000 (Lot serial: ALL LOTS); Model Catalog: VKMO 50000 (Lot serial: ALL LOTS); Model Catalog: VKMO 70000 (Lot serial: ALL LOTS); Model Catalog: BE-VKMO 51000 (Lot serial: ALL LOTS); Model Catalog: BO-VKMO 31000 (Lot serial: ALL LOTS); Model Catalog: VKMO 30000 (Lot serial: ALL LOTS); Model Catalog: VKMO 31000 (Lot serial: ALL LOTS); Model Catalog: HQV 55806 (Lot serial: ALL LOTS); Model Catalog: HMOD 70000-USA (Lot serial: ALL LOTS); Model Catalog: HQV 56103 (Lot serial: ALL LOTS); Model Catalog: BEQ-HMOD 70000-USA (Lot serial: ALL LOTS); Model Catalog: HQV 55808 (Lot serial: ALL LOTS); Model Catalog: BO-HQV 46901 (Lot serial: ALL L
  • Product Description
    STANDARD PUMP PACK BIOLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC