Events

Recall of CUSTOM PACK WITH SOFTLINE

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
    17225
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-08
  • 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
    New more stringent internal testing conducted by maquet cardiopulmonary to reduce the possibility of any quality issues in the field has indicated that specific oxygenator lots may not meet product specifications. specifically internal testing indicates that the outlet or/and inlet connector port of the unit may dislodge and separate from the main body of the oxygenator. please note that this recall pertains to specific lots of oxygenators. users need to continue to use the reusable mechanical clamp provided by maquet with all remaining maquet quadrox oxygenators currently in distribution. the specific lots within this recall may have an increased tendency for separation as indicated in the internal testing results.

Device

CUSTOM PACK WITH SOFTLINE
  • Model / Serial
    Model Catalog: BO-HQV 46901 (Lot serial: 92087670); Model Catalog: HQV 56103 (Lot serial: 70091907); Model Catalog: HQV 55806 (Lot serial: 70091907); Model Catalog: HQV 55806 (Lot serial: 92087265); Model Catalog: HQV 56103 (Lot serial: 92087265); Model Catalog: HQV 55806 (Lot serial: 92084433); Model Catalog: HQV 56103 (Lot serial: 92084433); Model Catalog: HQV 55806 (Lot serial: 92089326); Model Catalog: HQV 56103 (Lot serial: 92088079); Model Catalog: HQV 55806 (Lot serial: 92088079); Model Catalog: HQV 56103 (Lot serial: 92089326); Model Catalog: HMO 71000 (Lot serial: 70082790); Model Catalog: HMO 70000 (Lot serial: 70082790); Model Catalog: BE-PLS 2051 (Lot serial: 70075041); Model Catalog: HMO 71000 (Lot serial: 70082328); Model Catalog: HMO 70000 (Lot serial: 70082328); Model Catalog: VKMO 70000 (Lot serial: 70081881); Model Catalog: BEQ-HQV 46900 (Lot serial: 92098557); Model Catalog: BEQ-HQV 46900 (Lot serial: 92084424); Model Catalog: BEQ-HQV 46900 (Lot serial: 92096512); Model Catalog: BEQ-HQV 46
  • Product Description
    CUSTOM PACK WITH SOFTLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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