2 April 2025
- Alternative products – Public health services will be supplied alternative products by HealthShare Victoria. Although Reynard products containing alcohol have been released from quarantine, they will not be available to purchase until further notice due to relocation of the manufacturing site. Please see the alternative products section below for further information.
- Reporting of isolates – Follow the instructions under the ‘Reporting requirements in cases where Achromobacter isolates are identified from a sterile site (e.g. blood/CSF samples).
- Supply concerns - Escalate concerns about supply to HealthShare Victoria by emailing supplychainsurety@healthsharevic.org.au. For general enquiries, email CPLU@safercare.vic.gov.au
Overview
On 26 March 2025, the TGA issued a critical quarantine update regarding the potential bacterial contamination of certain Reynard Health products. Following further analysis, the TGA clarified that products containing 70% alcohol have not been linked to any reported cases of Achromobacter infection and are safe to use, allowing them to be removed from quarantine. However, health services must continue to follow the TGA’s Class I recall of three antiseptic products containing chlorhexidine as a single agent from Reynard Health Supplies.
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A TGA recall was issued following an adverse event report to the TGA identifying potential contamination of these products with Achromobacter bacteria.
Use of products contaminated with Achromobacter species can potentially result in serious infections (including sepsis and meningitis), which may be life-threatening for patients with compromised immune systems (please note, this species of bacteria cannot spread through airborne or aerosol transmission). To reduce the risk of patient harm, it is important that facilities identify and cease use of affected products immediately and implement the use of alternative antiseptic products.
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 have purchased alternative products for the state and are centralising store of these products.
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The following items should not be used:
ARTG number 309237
Sponsor Reynard Health SuppliesProduct code Product name Affected batches Expiry date RHS477 0.5% Chlorhexidine Foam Swabstick 240810 1 August 2027 RHS478 0.5% Chlorhexidine Lge Foam Swabstick 221010
210610
1 October 2025
1 June 2026RHS479 0.5% Chlorhexidine Prep Pads 6cm x 6cm 20200610
202311139 June 2025
- 9 November 2026
Following further analysis, the TGA has advised that products involved in the quarantine that contain 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 309541
Product code Product name 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 ARTG number 309237
Product code Product name 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 -
Recall management
- Check all potential storage areas for affected products, including trolleys, wound packs, bedside drawers, procedure kits, and first aid kits, with special attention to outpatient clinics and rooms.
- For products subject to the recall notice, facilities are advised to dispose of all stock of affected batches.
Clinical management
- There is a current outbreak of one strain of Achromobacter that has been linked to contaminated skin preparation products. Achromobacter is a germ that is occasionally isolated in clinical specimens
- Microbiological Diagnostics Unit (MDU) as the public health laboratory, will be undertaking genomics testing to determine whether any Achromobacter isolates grown from clinical samples from sterile sites (e.g. blood/CSF samples) are related to the outbreak strain.
- MDU have requested to primary labs to send any Achromobacter isolates to MDU for further genomic testing.
- Should any genomically-linked cases be identified, the Department of Health and Safer Care Victoria will be notified.
Joint safety statement when using topical Chlorhexidine
Please see the following guidance from the Australian Commission on Safety and Quality in Health Care regarding the appropriate and safe use of chlorhexidine in healthcare .
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- When Achromobacter isolates are identified from clinical samples from sterile sites (e.g. blood/CSF samples), the clinical samples need to be sent to the Microbiological Diagnostics Unit (MDU) for further genomic testing.
- The MDU as the public health laboratory, will be undertaking further genomic testing to determine whether Achromobacter grown from these clinical samples are related to the outbreak strain.
- The MDU will contact the organisation where the clinical sample was sent from with results.
- If the clinical sample from a sterile site (e.g. blood/CSF samples), has been identified as a potential Achromobacter outbreak link and sent to MDU, notification should be made to the Chief Medical Officer within Safer Care Victoria: CMO@safercare.vic.gov.au
- An escalation will then be made to the Chief Health Officer for further consideration and public management if applicable.
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The following products have been acquired by HealthShare Victoria and will be distributed to public health services:
Supplier Product code Description Solventum 101.06 3M SoluPrep Antiseptic Swab
6.35cm x 6.35cm x 200
70% Alcohol / 2% Chlorhexidine102.03 3M SoluPrep Antiseptic Swabstick Untinted Small 1.6mL x 50
70% Alcohol / 2% Chlorhexidine
102.09 3M SoluPrep Antiseptic Maxi Swabstick Tinted 5.2mLx 30
70% Alcohol / 2% Chlorhexidine
Escalate concerns about supply to HealthShare Victoria by emailing supplychainsurety@healthsharevic.org.au.
Reviewed 03 April 2025