Isoflurane vaporizers recalled over the potential for anesthesia leakage
Mindray is recalling 54 Isoflurane 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 Isoflurane (ISO) V90 Electronic Vaporizer, used with the Mindray A9 Anesthesia System, is being recalled. Affected items include the Iso E_Vap with safety filling adapter, part number 115-066758-00, and the exchange version of the same adapter.
The recall follows the potential for anesthesia leakage.
The recall covers 54 units, with part 115-066758-00 carrying DI 06936415975753 and identified by serial number. Distribution was worldwide, including in California, Florida, Georgia and Kentucky. 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
- Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Affected units
- 54
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 115-066758-00
- DI 06936415975753
- Serial Numbers: AH6B44000714
- AH6B44000719
- AH6B44000722
- AH6B44000724
- AH6B44000733
- AH6B44000734
- AH6B44000782
- AH6B45000836
- AH6B45000837
- AH6B45000840
- AH6B45000844
- AH6B45000858
- AH6B44000717
- AH6B44000786
- AH6B44000785
- AH6B44000788
- AH6B45000859
- AH6B44000671
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mindray DS USA, Inc. dba Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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