| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00319-1 |
| Product Name/Description |
LipiFlow System Activator
(used as part of the LipiFlow Thermal Pulsation System)
Model Number: LFD-1000
All Lots distributed between 1 Jan 2014 to 3 Feb 2017
Expiry Date: Jul 2017 to Feb 2021
ARTG Number: 189438 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is a labelling issue with specific lots of the LipiFlow System Activator. The Activator package label, box label, package insert and the Lipiflow System Instructions for Use (IFU) specify 10°C to 40°C for the Activator storage temperature. This specification was with the intent that the Activator would be stored in a temperature-controlled room environment (with heat and air conditioning) with allowance for occasional fluctuations between 10°C and 40°C.
Upon review, it has been determined that the labelled storage temperature should be consistent with the temperature conditions tested for the entire duration of the product shelf-life. Accordingly, the storage temperature on the Activator package and box labels has been revised to specify, “Store at controlled room temperature.” The revised package insert and the Lipiflow System IFU specify: “Store the Activator at controlled room temperature (20°C to 25°C) with short-term (< 72 hours) excursions permitted between 5°C and 38°C.” |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is requesting customers to read the enclosed "Summary of Important Labelling Changes for the LipiFlow System" and discontinue use of stock that are not in temperature-controlled environments (without heat and air conditioning). Customers are further requested to contact their local distributor to organise for replacement stock. This action has been closed-out on 23/06/2017. |
| Contact Information |
02 9006 1662 - Emergo |