| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00845-1 |
| Product Name/Description |
Americot Surgical Sponges (6mm x 6mm)
Lot Numbers: 2023/03 AQ, 2023/06 AP, 2023/10 BO, 2023/12 AY, 2024/05 AE, 2024/06 AQ
ARTG 265712
(Life Healthcare Pty Ltd - Neurosurgical sponges with XRD thread (Cotton) - Sponge, neuro) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
The X-ray detectable barium strip (aka radio-opaque marker) may become detached from the sponge (pattie).
The detachment of the X-ray detectable barium strip from the sponge may delay surgical process as the surgeon may require extra time to remove the markers from the surgical field. No serious adverse events related to the defect have been reported to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to inspect return all affected stock, including consigned products. Once returned, a replacement will be issued.
Life Healthcare will discard affected stock. |
| Contact Information |
1800 060 168 - Life Healthcare |