Events

Recall of MAQUET HLM Tubing Set with Bioline Coating with HG 0286 Connector

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
    56728
  • Event Risk Class
    Class 2
  • Event Number
    Z-0011-2011
  • Event Initiated Date
    2010-09-07
  • Event Date Posted
    2010-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94382
  • 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
    Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. leaks at the shank of the connector may result in air aspiration in the venous line.
  • Action
    Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form. Maquet Customer Service can bre contacted at 800-777-4222.

Device

MAQUET HLM Tubing Set with Bioline Coating with HG 0286 Connector
  • Model / Serial
    Lot number 70052718 and 70048867
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA State of IL and country of the Netherlands.
  • Product Description
    MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
  • 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