Events

Recall of Device Recall Anesthesia system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blease Medical Equipment, Ltd..

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
    55177
  • Event Risk Class
    Class 2
  • Event Number
    Z-1408-2010
  • Event Initiated Date
    2010-03-26
  • Event Date Posted
    2010-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90223
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. the lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. the vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
  • Action
    On 2/26/2010 notification letters were sent to all international consignees. The 2 domestic consignees were sent notification letters via FEDEX on 3/26/2010. The domestic consignees were also contacted by phone on 3/26/2010. The notification letter is titled URGENT MEDICAL DEVICE CORRECTION. It advises users of the issue and provides additional information which would permit the continued use of the Blease system until replacement back bar valves can be fitted by the recalling firm's service representatives. For users who choose to continue to use the device, the manufacturer recommends the use of an Agent Monitor and user education; also checks that vapourisers have been mounted correctly and the system is leak free, and testing in advance of a procedure. For additional questions, US Customers are directed to call Global Technical Support - +1 425-657-7200 ext: 5089. Non US Customers, call Global Technical Support - +44 1494 784422.

Device

Device Recall Anesthesia system
  • Model / Serial
    Serial numbers:  Siri 000116, Siri 000885, Siri 001100, Siri 001609, Siri 001610, Siri-001618, Siri-001626, Siri-001637, Siri-001640, Siri-001644, Siri-001658, Siri-001666, Siri-001667, Siri-001668, Siri-001674, AND Siri-001681.  Focu-000735, Focu-000737, Focu-000738, Focu-000739, Focu-000740, Focu-000741, Focu-000742, Focu-000743, Focu-000744, Focu-000745, Focu-000746, Focu-000747, Focu-000748, Focu-000749, Focu-000750, Focu-000751, Focu-100001, Focu-100003, Focu-100004, Focu-100005, Focu-100006, Focu-100007, Focu-100008, AND Focu-100009.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 2 U.S. hospitals and to customers in the following countries: Panama, Poland, Australia, Singapore, United Kingdom, Bangladesh, Nicaragua, Vietnam, Argentina, Finland, and Columbia.
  • Product Description
    The BleaseSirius and BleaseFocus Anaesthesia Systems.
  • Manufacturer
    Blease Medical Equipment, Ltd.

Manufacturer

Blease Medical Equipment, Ltd.
  • Manufacturer Address
    Blease Medical Equipment, Ltd., Deansway, Chesham, Bucks, England United Kingdom
  • Source
    USFDA