| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00250-1 |
| Product Name/Description |
KLARO In Vivo Surgical Lighting
Product number: 555-01-01
Lot numbers: 2212AI, 2104AG, 2108AH
ARTG 383587
(E & L May Pty Ltd - Open surgical site internal light source) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
E&L May is advising of a product related complaint for the KLARO lighting device which involved the splitting open of the top and bottom enclosures of the device.
There have been no reported harms due to this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should Inspect their stock immediately and quarantine any affected stock to prevent further use.
Let the company know via the customer acknowledgment form what affected product you have so they can be removed, and a credit issued.
Share this information with all appropriate personnel, including end-users, both within your organisation or externally where the potentially affected devices have been distributed.
This action has been closed out on 29/05/2024 |
| Contact Information |
07 3899 1300 - Andrew Brown. |