Critical recall/quarantine: Reynard antiseptic skin prep products

(TGA critical recall notice)

(Critical Quarantine notice - Victorian Department of Health)

(Latest update 28 March – Victorian Department of Health)

There is a potential for Achromobacter contamination with certain batches of antiseptic products. While some possible incidents are being investigated in Australia, there have been a number of cases of infection internationally. 

Contaminated products with Achromobacter can potentially result in serious infections, which may be life-threatening for patients with compromised immune systems, including neonates.

The announcement of the Critical Recall of certain batches of antiseptic products on 24 March was followed by a Critical Quarantine announcement of a broader range of products on 26 March.

While investigations are still ongoing, there is currently no confirmation that these specific Reynard products are contaminated. However, as a safety precaution, all affected stock must be quarantined immediately.

A critical quarantine, as defined by the TGA, requires the mandatory isolation and assessment of therapeutic goods to ensure they meet safety and quality standards. During this period, all customers and healthcare providers are urged to:

• Stop using the identified products immediately.
• Inspect and quarantine any remaining stock to prevent further use.

Alternatives to some of the products listed show no evidence of risk, such as:

• BD prepsticks (Chloraprep), which are sterile and manufactured in the USA.
• 3M Soluprep swabsticks, which are made in Canada.

The principles and recommendations outlined in the ANZCA/ACSQHC Joint Safety Statement on the topical application of chlorhexidine and the risks of accidental injection are still relevant and important. 

Contamination of the sterile setup with disinfectant solutions must be avoided and appropriate procedures must be in place to prevent cross-contamination of solutions intended for neuraxial injection with disinfectant preparations. 

For skin preparation for perineural and neuraxial procedures, 2% chlorhexidine in 70% alcohol is effective and may be considered, provided usual precautions are followed including allowing the skin preparation solution to dry completely, and pooling is avoided. An introducer needle for spinal anaesthesia is recommended. 

Alternatives for patients with a hypersensitivity to chlorhexidine include povidone iodine in 70% alcohol.

We continue to monitor the situation and will update this safety alert if new information becomes available.