| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00839-1 |
| Product Name/Description |
TB BIOPSY FORCEP OVAL CUP 2.3MM X 230CM
Part number: EBF33-11023230
Lot numbers: MEB231103011, MEB231103012, MEB231107019, MEB231107020
ARTG 260457
(Device Technologies Australia Pty Ltd - Endotherapy forceps, biopsy, flexible, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies (DT) identified a labelling problem with specific lot numbers (MEB231103011, MEB231103012, MEB231107019, MEB231107020 ) of the TB BIOPSY FORCEP OVAL CUP 2.3MM x 230CM.
The illustration on the product label is incorrect. The actual opening is 6.7mm, while the illustration on the label is 6.0mm. The physical product inside the packaging is consistent with the product specifications of 6.7mm jaw width.
Although the image of the opening width on the label does not match the actual product, the product reference code on the label is correct and corresponds to the actual product.
While this may lead to some confusion for doctors, it does not pose a risk of patient harm as the actual product’s opening width remains 6.7mm.
The 6.0mm option is not available in the Australian market (only the 6.7mm size is) so physicians can continue to utilise the product to which they are accustomed. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers are provided a Customer Letter that has an image of the incorrect illustration of opening width next to the correct illustration of the opening width. Customers are advised that although the image of the opening width on the label does not match the actual product, the product reference code on the label is in fact correct.
Device Technologies confirms that future batches will have a corrected label. |
| Contact Information |
0476 516 855 - ggainsford@device.com.au - Gina Gainsford |