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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 Getinge Australia Pty Ltd
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