Events

Recall of Device Recall Hemofiltration Standard Pack including BC 60 PlusT 8036

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet.

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
    78765
  • Event Risk Class
    Class 2
  • Event Number
    Z-0490-2018
  • Event Initiated Date
    2017-05-22
  • Event Date Posted
    2017-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160317
  • 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
    55 kits were distributed after their expiration date of september 2015.
  • Action
    Medical Device Recall (Removal) Notices were sent to customers via FedEx on 5/22/2017. The letters identified the affected device and the issue. Users are asked to examine their inventory to determine if any of the affected product is on hand. If found, affected devices should be removed and quarantined. Customers should contact Maquet/Getinge Customer Support at 1-888-627-8383 to obtain instructions on returning the affected devices. The Medical Device Recall Removal Response Form provided should be completed and returned. Questions should be directed to your Maquet/Getinge representative or call the Maquet/Getinge Customer Support at 1-888-627-8383.

Device

Device Recall Hemofiltration Standard Pack including BC 60 PlusT 8036
  • Model / Serial
    Lot/batch number: 3000001571 UDI code: 607567206489
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of NM, CA, and IL.
  • Product Description
    Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. || Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Manufacturer Address
    Maquet, 15 Law Dr, Fairfield NJ 07004-3206
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA