CLASS II ONGOING Device recall · Reported 11 Sep 2024 · FDA Enforcement Report
Sevoflurane E_Vap.(Safety Filling adapter) used recalled
Mindray DS USA is recalling Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to, distributed in 8 states. The recall was initiated on 22 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2950-2024
- FDA event ID
- 95099
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2024
- FDA classified
- 4 Sep 2024
- Reported
- 11 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 22 Jul 2024 | Recall initiated by company | |
| 4 Sep 2024 | Classified by FDA | +44 days |
| 11 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00
Where it was distributed
US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
CaliforniaGeorgiaKentuckyMississippiNew JerseyPuerto RicoTexasWest Virginia
Questions about this recall
Why was it 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
Which lots are affected?
UDI-DI: 06936415975777 Serial Number: AH6A28000471 AH6A24000202 AH6A28000474 AH6A27000378 AH6A28000466 AH6A24000195 AH6A28000457 AH6A25000237 AH6A28000426 AH6A24000199 AH6A24000207
Where was it sold?
US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95099| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Desflurane E_Vap.(Saf-T-Fill) used recalled by Mindray DS USA | Mindray DS USA | Packaging Defects | 8 states | |
| CLASS II | Isoflurane E_Vap.(Safety Filling adapter): used recalled | Mindray DS USA | Packaging Defects | 8 states | |
| CLASS II | Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA | Mindray DS USA | Packaging Defects | 8 states |
More recalls from Mindray DS USA
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
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