| TGA Action ID |
RC-2026-RN-00624-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hemospray Endoscopic Hemostat
Reference Part Number (RPN): HEMO-7, HEMO-10
Order Number: G56572, G21049
All Lot Numbers |
| ARTG Number |
509645 |
| Unique Device Identifier (UDI) |
00827002565722, 00827002210493 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Cook Medical is updating the Hemospray Instructions for Use (IFU) to include new guidance to address two Hemospray potential problems:
1. Endoscope adhesion and
2. Inability to spray powder.
Cook Medical is not removing devices from the field. |
| Instructions for Customers/Users |
Customers should;
1. Read the customer letter carefully and complete the Customer Response Form.
2. Share this notice with appropriate personnel, including down to the user level, within their organisation or with any organisation where the potentially affected products have been transferred. |
| Action Commencement Date |
14/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 777 222 - Cook Medical Customer Relations |