Type of Product |
Medical Device |
TGA Recall Reference |
RC-2024-RN-00805-1 |
Product Name/Description |
EZTest gas biological indicator (BI)
Part Number: EZG/6
Lot Number: G-248
Expiry date: 24/05/2026
ARTG 227233 (Getinge Australia Pty Ltd - Sterilization process indicator, biological) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
12/09/2024 |
Responsible Entity |
|
Reason/Issue |
An inaccurately certified population on the Certificate of Analysis (CoA) has been identified. It also impacts the Ethylene Oxide (EO) D value and the survival and kill times as the population is utilised to calculate these values. This recall does not impact the performance of the product or pose a safety problem to the end user.
A notable difference in population was identified and linked to the population recovery methodology between Mesa Labs-SDC and SAL and as such, Mesa Labs-SDC has recertified the population through in-house testing.
The corrected values meet the requirements of ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes. |
Recall Action |
Recall |
Recall Action Instructions |
Getinge will arrange for return and replacement of affected stock once the acknowledgement form is received. |
Contact Information |
1800 438 464 - Getinge Customer Service |