| TGA Action ID |
RC-2025-RN-00384-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Nasopore & Otopore Devices
Multiple product descriptions and affected lot numbers
ARTG's: 273654 & 274616 |
| ARTG Number |
273654, 274616 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging, acting as a sterile barrier. In such cases, it can be indicated that the sterility seal has been breached.
There is a potential for products with a breached sterility seal to be exposed to excessive pathogens, resulting in a possible increased risk of infection that may require medical intervention.
There have been no reports of illness or injury associated with this problem. |
| Instructions for Customers/Users |
· Customers are required to review the customer notification letter immediately and identify any affected products in their inventory.
· Customers are advised to dispose of the identified affected products.
· Customers to note that if they have loaned, sold or disposed of any product affected by the recall, they must immediately notify Stryker.
· Customers can expect to receive assistance from a Stryker representative who will coordinate the replacement of any affected products.
This action has been closed out on 11/12/2025. |
| Action Commencement Date |
9/04/2025 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com |