| TGA Action ID |
RC-2025-RN-00160-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
0.5% Chlorhexidine swab sticks foam, large foam swab sticks and prep pads 6 x 6 cm
Batch: 240810, 221010, 210610, 20200610, and 20231113
Expiry Date: 01 August 2027, 01 Oct 2025, 01 Jun 2026, 09 Jun 2025 and 09 Nov 2026
ARTG 309237 - Reynard Health Supplies (Aus) Pty Ltd - Skin-cleaning wipe, non-sterile |
| ARTG Number |
309237 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
Certain swab sticks and prep pads may be contaminated with Achromobacter species.
Contaminated products with Achromobacter can potentially result in serious infections, which may be life-threatening for patients with compromised immune systems.
Reynard Health has received reports of seven adverse events related to this problem. |
| Instructions for Customers/Users |
Customers are to inspect their stock immediately and quarantine all affected batches on hand to prevent further use.
Customers are to dispose of any stock on hand and for a credit contact enquiries@reynardhealth.com.au. Further instructions are in the customer letter.
Facilities are advised to consider reviewing previous laboratory findings of Achromobacter and consider tracing if possible.
Contact Reynard Health for clarification on affected products. Additional information and updates will be available once the investigation is complete.
UPDATE 21/03/2025: Reynard Health Supplies discovered that the affected batches had been sold to retailers and consumers.
If customers have supplied the product to another facility, they are to provide them with the customer letter immediately and ask them to follow the recall instructions.
Consumers may return the product to the place of purchase for a refund, or call Reynard Health to arrange the return of affected product and a refund.
This action has been finalised on 11/9/2025. |
| Action Commencement Date |
5/03/2025 |
| Responsible Entity |
|
| Contact Information |
0432 303 102 - Kristin Keyes |