| TGA Action ID |
RC-2025-RN-00664-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Colour Cuff Sterile Disposable Tourniquet Cuffs
Catalogue numbers: 5921-018-135, 5921-018-235, 5921-024-235
GTIN numbers: 07613154599257, 07613154599295, 07613154599370
Multiple lot numbers |
| ARTG Number |
304352 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is potential for the Tourniquet Cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain air pressure during surgical procedures.
A total of 51 complaints were reported, with no significant surgical delay or adverse consequences reported. |
| Instructions for Customers/Users |
Customers are to:
- Immediately review the Customer Notification Letter and quarantine any affected product.
- Inform Stryker if the affected product has been loaned, sold or disposed of.
A Stryker representative will help coordinate the replacement of any affected product.
This action has been closed out on 02/12/2025. |
| Action Commencement Date |
31/07/2025 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker Australia |