Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the… Recall
Issued September 11, 2024 · Mindray DS USA, Inc. dba Mindray North America
In September 2024, Mindray DS USA, Inc. dba Mindray North America recalled the Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
What you should do
- 1 Stop using Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Mindray DS USA, Inc. dba Mindray North America to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Health
- Recall date
- September 11, 2024
- Units affected
- Not reported
- Sold at
- US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and Internation
- Recall number
- FDA-Z-2952-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Mindray DS USA, Inc. dba Mindray North America has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.