Events

Recall of Haemonetics Cell Saver 5 Autogolous Blood Recovery System || Model Numbr: LN02005-110-E

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

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
    34372
  • Event Risk Class
    Class 2
  • Event Number
    Z-0822-06
  • Event Initiated Date
    2005-12-21
  • Event Date Posted
    2006-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43656
  • 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
    Apparatus, Autotransfusion - Product Code CAC
  • Reason
    Device emits radiofrequency which exceed the iec 60601-1-2 international standard.
  • Action
    Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .

Device

Haemonetics Cell Saver 5 Autogolous Blood Recovery System || Model Numbr: LN02005-110-E
  • Model / Serial
    Serial Numbers: 94H180CD-1; 95A048CS; 95J177CS
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Haemonetics Cell Saver 5 Autogolous Blood Recovery System || Model Numbr: LN02005-110-E
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Manufacturer Address
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Manufacturer Parent Company (2017)
    Haemonetics Corporation
  • Source
    USFDA