| TGA Action ID |
RC-2026-RN-00087-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Clinell Universal Wipes
Product Codes: CWBUC225AUS, CWBUC225RAUS
Multiple Lot Numbers |
| ARTG Number |
299351 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
GAMA Healthcare has received a small number of reports of contamination of its Clinell Universal range of buckets and refills. The common theme was dark/black marks visible at the top of the roll of wipes, easily identifiable when either product was opened.
Detailed analysis identified the presence of Cladosporium halotolerans.
This recall does not affect any other LOT (batch) or format of Clinell Universal wipes, nor any other GAMA Healthcare products. |
| Instructions for Customers/Users |
Customers should inspect their stock immediately and quarantine affected stock on hand to prevent further use prior to a local risk assessment being carried out.
GAMA Healthcare Australia would prefer customers destroy affected stock on hand of these batches, however can coordinate return and destruction if necessary. Replacements will be issued on return of the Customer Response Form.
Ensure relevant staff members are informed of this product alert, including infection prevent and control staff, cleaning staff and relevant clinicians who may decide to monitor for adverse events.
This action has been closed out on 25/05/2026 |
| Action Commencement Date |
4/02/2026 |
| Responsible Entity |
|
| Contact Information |
03 9769 6600 - GAMA Healthcare |