Sevoflurane E_Vap.(Safety Filling adapter) used with recall
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable…
Why was Sevoflurane 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: 06936415975777 Serial Number: AH6A28000471 AH6A24000202 AH6A28000474 AH6A27000378 AH6A28000466 AH6A24000195 AH6A28000457 AH6A25000237 AH6A28000426 AH6A24000199 AH6A24000207
- Product
- Sevoflurane 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
- 96 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)