| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00971-1 |
| Product Name/Description |
Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction Handle
Multiple Product Codes and Procedure Packs affected
ARTG Numbers: 137394, 137395, 136870, 140054, 140055, 140057, 140058, 140059, 140387, 161683, 161684, 161685 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medline is issuing an Instruction’s for Use (IFU) for the ConvaTec Unomedical brand Frazier Suction Handle. This action is being taken in response to complaints received by ConvaTec 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 is a low risk of tissue damage or the potential for debris to remain in the surgical field as a result of the device breaking. There have been no injuries reported 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. Medline is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 22/02/2017. |
| Contact Information |
1800 110 511 - Medline Customer Service Team |