Anesthesia vaporizers recalled over the potential for anesthesia leakage
Mindray is recalling 148 Sevoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: leakage from an anesthetic vaporizer is a hazard to the patient and the operating room, and no injuries are reported.
Plain-English summary
The Sevoflurane (SEVO) V90 Electronic Vaporizer, used with the Mindray A9 Anesthesia System, is being recalled. Affected items include the Sev E_Vap with safety filling adapter, part number 115-066756-00, and the exchange version of the same adapter.
The recall follows the potential for anesthesia leakage.
The recall covers 148 units, with part 115-066756-00 carrying DI 06936415975777 and identified by serial number. Distribution was worldwide, including in California, Florida, Georgia, Kentucky and Maryland. The FDA has classified the action as Class II.
A leaking vaporizer can release anesthetic agent into the room and affect the concentration delivered to the patient. The enforcement record reports no injuries. Facilities should follow Mindray's instructions.
The recalled product
- Product
- Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: Th
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- leakage
- anesthesia
- vaporizer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Part Number: 115-066756-00
- DI: 06936415975777
- Serial Numbers: AH6A45000871
- AH6A45000880
- AH6A45000881
- AH6A46000929
- AH6A46000931
- AH6A46000944
- AH6A47001200
- AH6A44000657
- AH6A44000658
- AH6A44000661
- AH6A44000664
- AH6A44000677
- AH6A44000678
- AH6A44000680
- AH6A44000768
- AH6A44000778
- AH6A46000925
- AH6A46000927
Distribution
Distributed nationwide across the United States.
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