Desflurane E_Vap.(Saf-T-Fill) 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: Part Number115-066759-00
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI:06936415975760 Serial Number: AH6C25000263 AH6C25000255 AH6C27000355 AH6C27000346 AH6C27000371 AH6C25000256 AH6C25000296 AH6C25000290 AH6C27000361 AH6C25000254 AH6C25000254 AH6C25000271 AH6C25000298 AH6C25000299 AH6C25000300 AH6C25000301 AH6C25000302 AH6C27000339 AH6C27000343 AH6C27000344 AH6C27000347 AH6C27000348 AH6C27000350 AH6C27000352 AH6C27000354 AH6C27000358 AH6C27000359 AH6C27000363 AH6C27000364 AH6C27000366 AH6C27000410 AH6C27000411 AH6C28000444 AH6C28000447 AH6C28000448 AH6C28000449 AH6C28000450 AH6C28000454
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mindray DS USA, Inc. dba Mindray North America
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Desflurane E_Vap.(Saf-T-Fill) 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: Part Number115-066759-00
Product Codes/Lot Numbers:
UDI-DI:06936415975760 Serial Number: AH6C25000263 AH6C25000255 AH6C27000355 AH6C27000346 AH6C27000371 AH6C25000256 AH6C25000296 AH6C25000290 AH6C27000361 AH6C25000254 AH6C25000254 AH6C25000271 AH6C25000298 AH6C25000299 AH6C25000300 AH6C25000301 AH6C25000302 AH6C27000339 AH6C27000343 AH6C27000344 AH6C27000347 AH6C27000348 AH6C27000350 AH6C27000352 AH6C27000354 AH6C27000358 AH6C27000359 AH6C27000363 AH6C27000364 AH6C27000366 AH6C27000410 AH6C27000411 AH6C28000444 AH6C28000447 AH6C28000448 AH6C28000449 AH6C28000450 AH6C28000454
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2952-2024
Related Recalls
Potential for anesthesia leakage.
Potential for anesthesia leakage.
Potential for activation of an abnormal alarm pause.