Reynard Health chlorhexidine and alcohol products recall

The following items should not be used:

ARTG number 309237
Sponsor Reynard Health Supplies

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

ARTG number 309237

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.
• Please see the Safer Care Victoria Guidance for managing the shortage of antiseptic products for further information.

To manage the shortage and minimise risks to patient safety, clinicians should:

• Use alternative antiseptic products: Where possible, select like-for-like products (for example, similar concentration and application style). A table of recommended alternatives is provided below. Ensure alternatives are compatible with the intended clinical use (e.g., skin preparation for injections or surgical procedures).
• Assess patient suitability: The patient’s allergy status must be checked and documented prior to the use of antiseptic products.
• Follow safe application protocols: Use of the product needs to be in accordance with the manufacturer’s Instructions for Use (IFU) and avoid wastage.
• Bottles and ampoules containing antiseptics: Use only when single use products are not available. Bottles and ampoules are for single patient use only and the remaining solution must be immediately discarded after use. Where products are in limited supply, follow the guidance from the Australasian College for Infection Prevention and Control (ACIPC) to reduce risk of contamination and inadvertent injection.
• Monitor supply and escalate concerns: Regularly review stock levels and escalate supply issues to HealthShare Victoria via email supplychainsurety@healthsharevic.org.au. For general inquiries, email CPLU@safercare.vic.gov.au.

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 settings.

• 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.

The following alternative products includes products available for health services to order direct from the supplier and products that have been acquired by HealthShare Victoria and will be distributed to public health services:

Product image	Product details	Availability status
	3M SoluPrep Antiseptic Swab 6.35cm x 6.35cm x 200 (70% Alcohol / 2% Chlorhexidine Prep Pad) SPN: 101.06	From 01/04/2025
	3M SoluPrep Antiseptic Swabstick Untinted Small 1.6mL x 50 (70% Alcohol / 2% Chlorhexidine Swabstick) SPN: 102.03	From 01/04/2025
	3M SoluPrep Antiseptic Maxi Swabstick Tinted 5.2mLx 30 (70% Alcohol / 2% Chlorhexidine Swabstick) SPN: 102.09	From 01/04/2025
	Briemar Sterile Skin Cleansing Swabs 5.6cm x 3cm 70% IPA BOX 200 (70% Alcohol Prep Pad) SPN: 5730/200	Available soon
	Swab, Sterile Alcohol 70% IPA, 50X55mm ,(Briemar), BOX 200 (70% Alcohol Prep Pad) SPN: 5055/200	Available soon
	Reynard Health Supplies 2% Chlorhexidine & 70% Alcohol Prep Pads 6 cm x 6 cm x 200 (70% Alcohol / 2% Chlorhexidine Prep Pad) SPN: RHS401	Early May