Events

Recall of Device Recall Disposable Set for autologous blood cell recovery

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
    25342
  • Event Risk Class
    Class 3
  • Event Number
    Z-0502-03
  • Event Initiated Date
    2002-12-17
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25631
  • 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
    Disposable Set for autologous blood cell recovery - Product Code CAC
  • Reason
    Disposable set for autologous blood recovery may leak saline at the y-connector.
  • Action
    Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.

Device

Device Recall Disposable Set for autologous blood cell recovery
  • Model / Serial
    KK02003 KK02011 KK02012 KK02014 KK02020 KK02100 LL02001 LL02009 LL02015 LL02022
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada
  • Product Description
    Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack || List Number: 265
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Manufacturer Address
    Haemonetics Corporation, 400 Wood Road, Braintree MA 02184
  • Source
    USFDA