| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00757-1 |
| Product Name/Description |
Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments
All A0282 and A0313 batches affected, supplied with instruments and separately.
Item numbers of A0282 compatible instruments: A22091A, A42091A, A4743, A4764, A4773
Item numbers of A0282 compatible instruments: A4772, A4776, A37005A
ARTG Number: 188523 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Olympus Winter & Ibe have identified specific item codes of Sealing Caps are missing information on the packaging that identifies the product as single-use and the sterility status of the Sealing Caps. These items are supplied unsterile and intended for single-use only following sterilisation. Since there is no indication for single-use on the label it may be interpreted that the sealing cap can be reused. To date, Olympus has not received any reports regarding adverse events or patient injury relating to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Olympus is advising users to inspect their inventory for the affected Sealing caps and discard. Olympus will provide corrected replacement stock.
This action has been closed out on 21/09/2018 |
| Contact Information |
1300 657 699 - Olympus Customer Service |