Retiro De Equipo (Recall) de LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation System)

Recall

RC-2017-RN-00319-1

Class III

2017-03-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00319-1

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.”.

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.