Events

Recall of ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION

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
    58658
  • Event Risk Class
    Class 2
  • Event Number
    Z-2420-2011
  • Event Initiated Date
    2011-04-29
  • Event Date Posted
    2011-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99797
  • 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
    2 models model 1: orthopat devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled model 2: orthopat equipped with a spill collection drainage system updated with revised instructions for use and quick reference guide addendum.
  • Action
    The firm, Haemonetics, sent an "Urgent Field Recall" letter dated April 29, 2011 to all customers. The letter describes the product, problem and actions to be taken. This recall covers the 2 models. Model 1: OrthoPAT devices without drain ports (Serial numbers 00001 through 02279-T). All OrthoPAT devices without drain ports worldwide, will be removed from distribution and scrapped. Model 2: OrthoPAT devices with drain ports (serial numbers beginning with 02280-T and higher). All OrthoPAT devices with drain ports will remain in clinical use and will receive updated labeling. The customers were instructed to follow the enclosed directions to confirm their possession of any units of this model and arrange for their return to Stericycle; immediately cease use of devices not equipped with a spill collection drainage system ( to determine whether their OrthoPAT device is equipped with the spill collection drainage system, please refer to the attached illustrations/instructions); complete and return the IMPORTANT-CUSTOMER CONFIRMATION sheet via fax to: Stericycle at 1-866-792-5450, and RETURN the OrthoPAT devices NOT equipped with spill collection drainage system (for instructions on how to arrange return of OrthoPAT Devices, call a Stericycle Representative at 1-866-918-8736). A Haemonetics representative will be in contact with the customers facility within 14 working days to assist with the recall actions. The firm, Haemonetics, will update the OrthoPAT labeling. The labeling will have specific instructions to permanently deploy the centrifuge spill collection bag at all times. Device cleaning instructions in the event of a blood spill are also clarified and include specific instructions to unplug the device from the AC outlet in the event of a fluid spill on the device. If a device does experience a fluid spill, new instructions direct the user to return the device to Haemonetics for evaluation and repair. Operator Manuals will be replaced with a new revisi

Device

ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION
  • Model / Serial
    Model 1: No Spill Collection System Serial numbers 00001 through 02279-T Model 2: Serial numbers beginning with 02280-T
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Austria, Australia, Belgium, Switzerland, Canada, China, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Guatemala, Ireland, Israel, India, Italy, Japan, Lithuania, Luxembourg, Latvia, Monaco, Netherlands, Norway, Panama, Poland, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, Slovak Republic, EI Salvador, Turkey and Taiwan.,
  • Product Description
    Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System || US Only: 1050-110-ENG || Outside US: || 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, || 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. || Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.
  • 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