Events

Recall of Device Recall Haemonetics

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
    32844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0174-06
  • Event Initiated Date
    2005-07-22
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40930
  • 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
    Blood clotting of patient post operative while on the cardiopat cardiovascular perioperative autotransfusion system.
  • Action
    Haemonetics issued a recall notification via Certified Mail on 7/22/05 to four user sites requesting return of the machine and all disposables received.

Device

Device Recall Haemonetics
  • Model / Serial
    All lot numbers
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, MN, NE, TX
  • Product Description
    cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E || and Disposables: || cardioPAT Replacement RBC Bags, LN 00270 || cardioPAT Replacement Waste Bags, LN 00271 || cardioPAT Replacement Intraoperative Suction Set, LN 00272 || cardioPAT Replacement Postoperative Suction Set, LN 00273 || cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 || cardioPAT Replacement One-Way Valve Assembly LN 00275
  • 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