Events

Recall of A3/A5 Anesthesia Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. d.b.a. Mindray North America.

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
    63314
  • Event Risk Class
    Class 1
  • Event Number
    Z-0290-2013
  • Event Initiated Date
    2012-08-13
  • Event Date Posted
    2012-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113481
  • 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
    Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on a3/a5 anesthesia delivery systems. a potential system leak resulting from the canister gasket will likely present itself during the automatic circuit leak and compliance test performed at startup and the manual leak test recommended to be performed before each case.
  • Action
    The firm, Mindray DS USA Inc., sent an "URGENT: A3/A5 ANESTHESIA DELIVERY SYSTEM CORRECTIVE ACTION" letter dated August 13, 2012 to their customers via Certified Mail return receipt requested. The letter described the product, problem and actions to be taken. The customers were instructed to route this letter to all potential uses of the product within their facility; increase fresh gas flow, should the leak occur during use, to compensate for any pressure loss resulting from the leak; alternatively, the absorber canister may be unlocked and locked again to reseat the gasket and verify that the canister and gasket are fully seated, a leak test is performed after replacement of the Pre-Pak or loose-fill absorbent and also be performed before each patient use until the canister gaskets are replaced on systems in their facility. A Mindray Representative will replace the canister gasket to correct the issue. If you have any questions or need to arrange for a replacement of the absorber canister gasket on the A3/A5 System(s) in your facility, contact your Mindray Service Representative, at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm). A press release was issued by the firm on 11/14/2012.

Device

A3/A5 Anesthesia Delivery System
  • Model / Serial
    0633F-01000-00 Various serial numbers  0633F-01000-00 FA-1A000033 0633F-01000-00 FA-1A000023 0633F-01000-00 FA-21000072 0633F-01000-00 FA-1A000029 0633F-01000-00 FA-21000085 0633F-01000-00 FA-19000011 0633F-01000-00 FA-19000008 0633F-01000-00 FA-19000009 0633F-01000-00 FA-1A000027 0633F-01000-00 FA-1A000047 0633F-01000-00 FA-1A000055 0633F-01000-00 FA-1A000041 0633F-01000-00 FA-1A000053 0633F-01000-00 FA-1B000056 0633F-01000-00 FA-21000080 0633F-01000-00 FA-19000007 0633F-01000-00 FA-19000013 0633F-01000-00 FA-21000066 0633F-01000-00 FA-21000078 0633F-01000-00 FA-19000012 0633F-01000-00 FA-19000017 0633F-01000-00 FA-1A000021 0633F-01000-00 FA-1A000028 0633F-01000-00 FA-1A000038 0633F-01000-00 FA-1A000045 0633F-01000-00 FA-1A000035 0633F-01000-00 FA-1A000037 0633F-01000-00 FA-1A000026 0633F-01000-00 FA-1A000030 0633F-01000-00 FA-1A000048 0633F-01000-00 FA-1A000040 0633F-01000-00 FA-1B000059 0633F-01000-00 FA-1A000034 0633F-01000-00 FA-1A000049 0633F-01000-00 FA-21000062 0633F-01000-00 FA-21000064 0633F-01000-00 FA-21000074 0633F-01000-00 FA-21000082 0633F-01000-00 FA-21000090 0633F-01000-00 FA-1A000022 0633F-01000-00 FA-1A000051 0633F-01000-00 FA-1A000052 0633F-01000-00 FA-1A000042 0633F-01000-00 FA-1A000050 0633F-01000-00 FA-1B000057 0633F-01000-00 FA-1B000061 0633F-01000-00 FA-1A000025 0633F-01000-00 FA-1A000031 0633F-01000-00 FA-1A000036 0633F-01000-00 FA-1A000044 0633F-01000-00 FA-21000076 0633F-01000-00 FA-21000077 0633F-01000-00 FA-21000088 0633F-01000-00 FA-1A000043 0633F-01000-00 FA-1A000032 0633F-01000-00 FA-1A000046 0633F-01000-00 FA-1B000058 0633F-01000-00 FA-1B000060 0633F-01000-00 FA-19000010 0633F-01000-00 FA-19000015 0633F-01000-00 FA-21000086
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
  • Product Description
    Mindray A3 Anesthesia Delivery System || Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 || This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
  • Manufacturer
    Mindray DS USA, Inc. d.b.a. Mindray North America

Manufacturer

Mindray DS USA, Inc. d.b.a. Mindray North America