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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00583-1
Product Name/Description	Promed Hospital Grade Disinfectant Wipes Batch Numbers: AB19-8, AB20-9, AB22-7, AB25-B, AB33-6, AB34-8, AB36-5, AB37-A, AB37-1, AB37-4, AB38-A, AB40-B, AB40-9 Product Reference Code: PMDNW7000 ARTG 374835 (Textor Converting Pty Ltd - ISO- Clean Professional Hospital Grade Disinfectant wipes - Disinfectant, hospital grade)
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	17/07/2024
Responsible Entity	Textor Converting Pty Ltd
Reason/Issue	Textor Converting Pty Ltd has identified an unusual aroma in Promed Hospital Grade Disinfectant Wipes. Investigations have identified trace amounts of impurities which, while posing no safety or efficacy risks, resulted in this unusual aroma. Although these impurities do not introduce any safety risks and do not reduce efficacy, this alteration in aroma may raise concern.
Recall Action	Recall
Recall Action Instructions	Customers are advised to identify all affected lot numbers of Promed Hospital Grade Disinfectant wipes and notify their distributor (Thermo Fisher) and Textor Converting Pty Ltd. Thermo Fisher will provide a credit and replace product if desired. Affected product can be disposed of.
Contact Information	0421 271 769 - Textor Converting