Agency classClass IIOur severity:High FDA (Devices)·Z-2689-2016·Announced 2016-09-07

Mindray A7 Anesthesia Delivery System Recalled for Potential Oxygen Leak

Mindray is recalling 167 A7 Anesthesia Delivery Systems due to a potential leak on the back-up oxygen and air cylinder yokes.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential leak in a critical life-support device. No injuries or illnesses are reported in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling 167 units of the A7 Anesthesia Delivery System. This device is used to administer general inhalation anesthetics and maintain patient ventilation. The recall involves part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international).

The recall is being conducted because of a potential for a leak to occur on the back-up O2 and air e-size cylinder yokes. The affected units were distributed nationwide in the US to Alabama, Massachusetts, Maryland, Minnesota, Missouri, Nebraska, New Jersey, Oklahoma, Oregon, Pennsylvania, and Virginia, as well as to Canada.

Healthcare facilities should stop using the affected devices and contact Mindray for further instructions. The specific serial numbers for the 167 affected units are listed in the official recall documentation.

The recalled product

Product: A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Category: Medical Device — Anesthesia Delivery System
Hazard: gas-leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

FR-5B000342
FR-5B000343
FR-5B000348
FR-5B000349
FR-51000148
FR-51000149
FR-51000150
FR-51000151
FR-51000152
FR-51000153
FR-51000154
FR-51000159
FR-51000161
FR-51000162
FR-51000163
FR-51000164
FR-51000165
FR-51000166
FR-51000167
FR-51000168

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Same manufacturer · Mindray DS USA, Inc. dba Mindray North America

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