A Critical Quarantine update was issued by the Therapeutic Goods Administration (TGA) on 26 March 2025 affecting Reynard Health Supply products. This notice was to advise of potential bacterial (Achromobacter) contamination affecting certain batches of the Reynard Health products listed below.
Contaminated products may result in serious infections, which may be life-threatening for patients with compromised immune systems.
Background
Quarantined products include antiseptic wipes, swabs and prep pads used to clean skin prior to a procedure or device application, and to disinfect wounds prior to the application of dressings.
Products containing povidone-iodine are generally reserved for procedures where chlorhexidine is not appropriate/contraindicated such as those with chlorhexidine allergy.
Latest updates
Further update - 28 March
This is a rapidly evolving situation, and the Therapeutic Goods Administration (TGA) has advised that following further analysis of the current situation that products containing 70% alcohol have not been implicated in any of the reported cases of the Achromobacter infection.
The following products containing alcohol have been released from quarantine and are safe to use:
ARTG number | Product code | Product name |
---|---|---|
309541 | RHS417 | 70% Isopropyl Alcohol Prep Pads 6 cm x 6 cm |
RHS451G | 70% Isopropyl Alcohol Prep Pads 6 cm x 3 cm | |
RHS438 | Premium 70% Isopropyl Alcohol Prep Pads 4.5 cm x 8.5 cm | |
309237 | RHS401 | 2% Chlorhexidine & 70% Alcohol Prep Pads 6 cm x 6 cm |
RHS408 | 2% Chlorhexidine & 70% Alcohol Regular Cotton Swabsticks | |
RHS408EP | 2% Chlorhexidine & 70% Alcohol Easy Peel Cotton Swabsticks | |
RHS408T | 2% Chlorhexidine & 70% Alcohol Cotton Swabsticks Triple Pack | |
RHS408TR | 2% Chlorhexidine & Alcohol Tinted Swabsticks | |
RHS422 | 2% Chlorhexidine & 70% Alcohol Prep Pads 20 cm x 16 cm | |
RHS422EP | 2% Chlorhexidine & 70% Alcohol Easy Peel Prep Pads 20 cm x 16 cm | |
RHS437 | Premium 2% Chlorhexidine & 70% Alcohol Prep Pads 4.5 cm x 8.5 cm | |
RHS461 | 2% Chlorhexidine & 70% Alcohol Prep Pads 6 cm x 3 cm | |
RHS470 | 0.5% Chlorhexidine & 70% Alcohol Regular Foam Swabsticks | |
RHS470TR | 0.5% Chlorhexidine & 70% Alcohol Tinted Foam Swabsticks | |
RHS471 | 0.5% Chlorhexidine & 70% Alcohol Large Tinted Foam Swabsticks | |
RHS472 | 2% Chlorhexidine & 70% Alcohol Large Tinted Foam Swabsticks | |
RHS473 | 2% Chlorhexidine & 70% Alcohol Regular Foam Swabsticks | |
RHS474 | 2% Chlorhexidine & 70% Alcohol Large Foam Swabsticks |
Health services must continue to adhere to the TGA Class I recall of three antiseptic products from Reynard Health Supplies (TAG reference: RC-2025-RN-00160-1).
The following products should not be used:
ARTG number | Product code | Product name |
---|---|---|
309237 | RHS477 | 0.5% Chlorhexidine Foam Swabstick |
RHS478 | 0.5% Chlorhexidine Lge Foam Swabstick | |
RHS479 | 05% Chlorhexidine Prep Pads 6cm x 6cm |
There will be a disruption in supply of Reynard's products over the next 12 weeks. HealthShare Victoria has secured alternative stock to provide to Victorian Public Health Services during this period of disrupted supply.
HealthShare Victoria will coordinate this supply to health services. The situation will continue to be monitored during this time.
This is a rapidly evolving situation and Safer Care Victoria alongside the Department of Health will continue to provide critical updates as they are available. In addition, these updates will also be available on this webpage.
Therapeutic Goods Administration update
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The TGA is working to further risk assess the quarantines products. Victoria is sourcing supply of alternative products to minimise the impact of this quarantine. Please do not destroy affected products.
Health services must continue to adhere to the TGA Class I recall of three antiseptic products from Reynard Health Supplies (TAG reference: RC-2025-RN-00160-1).
The following products should not be used:
ARTG number Product code Product name 309237 RHS477 0.5% Chlorhexidine Foam Swabstick RHS478 0.5% Chlorhexidine Lge Foam Swabstick RHS479 05% Chlorhexidine Prep Pads 6cm x 6cm
A Victorian Response Group has been formed to address and understand potential impacts on clinical care delivery. The group includes representatives from the Department of Health, Safer Care Victoria, HealthShare Victoria, and clinicians.HealthShare Victoria are working on purchasing alternative products for the state and centralising store of these products.
Interim solutions
- Use alternative products where possible. Products from alternative suppliers containing the following active ingredients are suitable substitutes:
- 2% Chlorhexidine
- 70% Alcohol
- 70% Alcohol & 0.5% Chlorhexidine
- 70% Alcohol & 2% Chlorhexidine
- Isopropyl alcohol
- Povidone-iodine plus/minus alcohol
- Health services should undertake a risk-based assessment and are encouraged to consult with their local infectious disease specialists for further advice.
- Where suitable alternatives are not available, consideration can be given where there is minimal risk to use the following products:
ARTG number Product code Product name 309541 RHS417 70% Isopropyl Alcohol Prep Pads 6 cm x 6 cm RHS451G 70% Isopropyl Alcohol Prep Pads 6 cm x 3 cm RHS438 Premium 70% Isopropyl Alcohol Prep Pads 4.5 cm x 8.5 cm 309237 RHS401 2% Chlorhexidine & 70% Alcohol Prep Pads 6 cm x 6 cm RHS408 2% Chlorhexidine & 70% Alcohol Regular Cotton Swabsticks RHS408EP 2% Chlorhexidine & 70% Alcohol Easy Peel Cotton Swabsticks RHS408T 2% Chlorhexidine & 70% Alcohol Cotton Swabsticks Triple Pack RHS408TR 2% Chlorhexidine & Alcohol Tinted Swabsticks RHS422 2% Chlorhexidine & 70% Alcohol Prep Pads 20 cm x 16 cm RHS422EP 2% Chlorhexidine & 70% Alcohol Easy Peel Prep Pads 20 cm x 16 cm RHS437 Premium 2% Chlorhexidine & 70% Alcohol Prep Pads 4.5 cm x 8.5 cm RHS461 2% Chlorhexidine & 70% Alcohol Prep Pads 6 cm x 3 cm RHS470 0.5% Chlorhexidine & 70% Alcohol Regular Foam Swabsticks RHS470TR 0.5% Chlorhexidine & 70% Alcohol Tinted Foam Swabsticks RHS471 0.5% Chlorhexidine & 70% Alcohol Large Tinted Foam Swabsticks RHS472 2% Chlorhexidine & 70% Alcohol Large Tinted Foam Swabsticks RHS473 2% Chlorhexidine & 70% Alcohol Regular Foam Swabsticks RHS474 2% Chlorhexidine & 70% Alcohol Large Foam Swabsticks Considerations
- If alternative products are available but in limited supply, consider prioritising their use according to patient risk stratification (e.g. avoid using affected products with vulnerable/immunocompromised patients, including those with cancer, cystic fibrosis, organ transplantation, and renal disease requiring dialysis).
- Use bottled chlorhexidine and/or alcohol where appropriate. If using bottled chlorhexidine, please follow local processes on use and storage.
- When using these products, remain vigilant in allowing the solution to fully dry on the skin or device (cannula/ IV hub/vial etc) before injection/cannulation.
- For patients with chlorhexidine allergy/sensitivity, carefully check alternative product labelling to exclude the presence of chlorhexidine.
Next steps
This is a rapidly evolving situation and Safer Care Victoria alongside the Department of Health will continue to provide critical updates as they are available. In addition, these updates will also be available on this webpage.
- Use alternative products where possible. Products from alternative suppliers containing the following active ingredients are suitable substitutes:
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Overview
A Critical Quarantine update was issued by the Therapeutic Goods Administration (TGA) on 26 March 2025 affecting Reynard Health Supply products. This notice was to advise of potential bacterial (Achromobacter) contamination affecting certain batches of the Reynard Health products listed below.
Contaminated products may result in serious infections, which may be life-threatening for patients with compromised immune systems.
Background
Quarantined products include antiseptic wipes, swabs and prep pads used to clean skin prior to a procedure or device application, and to disinfect wounds prior to the application of dressings.
Products containing povidone-iodine are generally reserved for procedures where chlorhexidine is not appropriate/contraindicated such as those with chlorhexidine allergy.
Actions
A Victorian Response Group has been formed to address this issue and understand potential impacts on clinical care delivery. The group includes representatives from the Department of Health, Safer Care Victoria, HealthShare Victoria, and clinicians.
HealthShare Victoria are working on purchasing alternative products for the state and centralising store of these products. HealthShare Victoria is contacting health services individually to assess stock levels and projected requirements.
Representatives from Victoria are meeting with the TGA alongside other jurisdictions today. You will be provided with a further update via email. These updates will also be available on this webpage and will include alternative products, associated timelines and actions health services are advised to take.
This is a rapidly evolving situation and Safer Care Victoria alongside the Department of Health will continue to provide critical updates.
Impacted products
Item Product Description RHS475 Reynard Swabstick 2% Chlorhexidine RHS421 Reynard Prep Pads 2% Chlorhexidine 4.5cm x 8.5cm RHS417 Reynard Swabstick 70% Alcohol 6cm x 6cm RHS438 Reynard Prep Pads 70% Alcohol 4.5cm x 8.5cm RHS451G Reynard Prep Pads 70% Alcohol 6cm x 6cm RHS471 Reynard Swabstick Large 70% alcohol & 0.5% Chlorhexidine RHS408 Reynard Swabsticks 70% alcohol & 2% Chlorhexidine RHS408EP Reynard Swabsticks Easy Peel Sachet 70% alcohol & 2% Chlorhexidine RHS408T Reynard Swabsticks Triple Pack 70% alcohol & 2% Chlorhexidine RHS408TR Reynard Swabsticks Tinted 70% alcohol & 2% Chlorhexidine RHS461 Reynard Swabstick Small 70% alcohol & 2% Chlorhexidine 6cm x 3cm RHS470 Reynard Swabsticks 70% alcohol & 2% Chlorhexidine RHS470TR Reynard Swabstick Tinted 70% alcohol & 2% Chlorhexidine RHS472 Reynard Swabstick Large 70% alcohol & 2% Chlorhexidine RHS473 Reynard Swabstick 70% alcohol & 2% Chlorhexidine RHS474 Reynard Swabstick Large 70% alcohol & 2% Chlorhexidine RHS401 Reynard Prep Pads Medium 70% alcohol & 2% Chlorhexidine 6cm x 6cm RHS422 Reynard Prep Pads Large 70% alcohol & 2% Chlorhexidine 20cm x 16cm RHS422EP Reynard Prep Pads Large 70% alcohol & 2% Chlorhexidine RHS437 Reynard Prep Pads Premium 70% alcohol & 2% Chlorhexidine 4.5cm x 8.5cm RHS457 Reynard Adhesive Removal Wipes 6cm x 6 cm
Reviewed 28 March 2025