| TGA Action ID |
RC-2026-RN-00787-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Sevoflurane Vaporizers
Vaporizer Sevoflurane Safe-T-Seal
Part Number: 6887135
Serial Numbers: 30144 - 30731, 31026 - 31061, 31066, 31069, 31070
Vaporizer Sevoflurane Maquet filling
Part Number: 6682282
Serial Numbers: 30000 - 30911, 33065, 33074, 33077, 33078, 33086 |
| ARTG Number |
180464 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Maquet Critical Care AB has identified a problem affecting certain batches of Sevoflurane vaporizers that were not manufactured according to specification. Components within the affected vaporizers may not perform as intended over time, which could affect the long-term performance of the devices.
To date, no patient or operator injuries have been reported. Affected vaporizers are being recalled and replaced with conforming units. |
| Instructions for Customers/Users |
Customers are to:
- Continue using affected vaporizers in accordance with the instructions provided in the customer letter until replacement vaporizers are supplied.
- Empty and dry-run the vaporizer if sevoflurane is not expected to be used within the next 30 days or before external transportation.
- Before use, verify that sevoflurane has been used within the previous 30 days; if not, discard the sevoflurane and empty and dry-run the vaporizer in accordance with the provided instructions. |
| Action Commencement Date |
15/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 438 464 - Customer Service |