Agency classClass IOur severity:Severe FDA (Devices)·Z-0290-2013·Announced 2012-11-28

Mindray A3 Anesthesia Delivery System Recalled for Potential System Leak

Mindray is recalling 69 A3 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Mindray DS USA, Inc. is recalling 69 units of the Mindray A3 Anesthesia Delivery System. The recall involves 61 units in the United States and 8 units in foreign countries. The affected devices were distributed nationwide in the US, including Puerto Rico, as well as in Australia, Chile, Colombia, and Venezuela.

The recall was initiated because Mindray identified a potential for a system leak resulting from an issue with the carbon dioxide absorber canister gasket. The company notes that this potential leak 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.

Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a device is affected, users should follow the instructions provided by Mindray regarding the leak tests and any necessary corrective actions.

The recalled product

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…
Manufacturer: Mindray DS USA, Inc. d.b.a. Mindray North America
Category: Medical Device — Anesthesia Delivery System
Hazard: system-leak

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Mindray DS USA, Inc. d.b.a. Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Mindray DS USA, Inc. d.b.a. Mindray North America

See all →

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Same hazard · system leak