| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00923-1 |
| Product Name/Description |
Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)
Product Codes: 309.02.006, 309.02.008, 309.02.008L, 309.02.010, 309.02.010L, 309.02.012, 309.02.012L
All lots affected
ARTG Number: 172620 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
ConvaTec (Australia) Pty Ltd is issuing an Instruction for Use (IFU) for their Unomedical brand Frazier Suction Instrument which currently is supplied without an IFU. This action is being taken in response to complaints from the users in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip.
If the issue were to occur, it would result in a loss of suction and loss of visibility in the surgical field. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer has decided to issue an IFU to instruct the users on how to use the product appropriately to avoid any breakage of the instrument. ConvaTec is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 07/02/2017. |
| Contact Information |
03 9239 2726 - ConvaTec |