| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00213-1 |
| Product Name/Description |
Sevoflurane Quik-Fil Vaporizer for Flow Family Anaesthesia systems
Item number: 6886611
ARTG 180464
(Getinge Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/02/2022 |
| Responsible Entity |
|
| Reason/Issue |
Getinge Australia is advising of eight complaints describing the presence of a yellow substance in the vaporizer. Hydrogen fluoride has been confirmed in one complaint by chemical analysis. While in one instance the complaint stated that a smell was detected, it was reported that for four complaints the vaporizers didn’t pass system checkout and that one unit had noted leakage.
The potential hazards that have been identified include inhalation of hydrogen fluoride. Potential harms may include irritation of respiratory tract and in worst case may lead to lung oedema and/or severe hypocalcaemia which may be delayed for 24-48 hours after exposure.
No patient or operator adverse events have been reported in any of these complaints. This issue has only been observed when using Sevoflurane Piramal and Baxter Sevoflurane. No complaints have been reported for Abbvie Sevorane/Ultane. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge is advising that the investigation to determine a root cause is ongoing and customers will be notified of the corrective action once identified.
In the interim customers are to follow the information in the customer letter (provided to affected customers):
- Should a Quik-Fil Vaporizer model 6886611 have been used with any other filing except for AbbVie Sevorane, users are to quarantine the device immediately to prevent further use. Please contact a Getinge Representative for a replacement. |
| Contact Information |
1800 438 464 - Getinge Customer Service |