Isoflurane E_Vap.(Safety Filling adapter): used with recall
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable…
Why was Isoflurane E_Vap.(Safety Filling adapter): used with recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 06936415975753 Serial Number: AH6B24000165 AH6B24000170 AH6B24000167 AH6B24000163 AH6B24000166 AH6B24000173 AH6B24000174 AH6B24000183
- Product
- Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable…
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 24 units
- Distribution
- US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
- Recall date
- September 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)