FDA Device recall Z-0290-2013
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a dev…
- FDA Device
- Class I
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class I recall of Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a dev… by Mindray Ds Usa D B A Mindray North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0290-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-13 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mindray Ds Usa D B A Mindray North America |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | 0633F-01000-00 Various serial numbers 0633F-01000-00 FA-1A000033 0633F-01000-00 FA-1A000023 0633F-01000-00 FA-210…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- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.