Events

Recall of Getinge Assure

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

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
    65866
  • Event Risk Class
    Class 2
  • Event Number
    Z-1994-2013
  • Event Initiated Date
    2013-08-02
  • Event Date Posted
    2013-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120574
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    Accufast biological indicator lot sr-430 may have been exposed to conditions affecting its viability. this could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
  • Action
    GETINGE sent an DEVICE CORRECTION NOTICE letter dated July 31, 2013, and response forms were sent to customers on August 2, 2013, via Certified Mail Return Receipt Requested. The letters instruct customers to immediately discontinue use, quarantine, and destroy the affected lot. In addition, they instruct customers to: Check the appropriate box and record the quantity of affected unused product on the enclosed Correction Response Form OR If if they do not have any lots of affected unused inventory check the box indicating such. Destroy the unused product in accordance with your institution's policy and instructions for use. Record the method of destruction on the Correction Response Form. Be sure to include the Facility Name, Address, Contact Name and Phone Number. Sign, date and e-mail the form back to SR430responseform@getinge.com within 10 days or sooner of receiving this notice. Credit will be issued upon receipt of the Correction Response Form. Replacement product of unaffected lots is currently available. The warehouse shipping the affected lot is no longer being used (due to business decision, not as result of this recall). The current warehouse is maintaining the product in a controlled temperature segregated room away from any potential sterilants. If you have any questions regarding this notification please call 1-800-475-1400 ext. 5026

Device

Getinge Assure
  • Model / Serial
    LOT SR-430 (Expiration 02/06/2014)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the country of Canada.
  • Product Description
    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. || Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
  • Manufacturer
    Getinge USA Inc

Manufacturer

Getinge USA Inc
  • Manufacturer Address
    Getinge USA Inc, 1777 E Henrietta Rd, Rochester NY 14623-3133
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA