Events

Recall of Device Recall Maquet HLM Tubing Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet 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
    56268
  • Event Risk Class
    Class 2
  • Event Number
    Z-2401-2010
  • Event Initiated Date
    2010-07-13
  • Event Date Posted
    2010-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93103
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
  • Reason
    The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
  • Action
    Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.

Device

Device Recall Maquet HLM Tubing Pack
  • Model / Serial
    Product number BEQ-TOP 14801; lot numbers 70040244, 70046759.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution: Pennsylvania
  • Product Description
    Maquet HLM Tubing Pack; Bioline Coating
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Manufacturer Address
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA