| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00908-1 |
| Product Name/Description |
Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)
ARTG Number: 168234 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Easypod injection device requires programming prior to supply to ensure the patient receives the correct dose. With the interruption in the supply of SAIZEN Solution for Injection, devices required reprogramming to take into consideration the change in concentration from either 5.83 mg/mL or 8 mg/mL available in the solution for injection presentations to only 5.83 mg/mL in the Click.easy powder for injection presentation. To mitigate against the risk of a patient receiving an incorrect dose due to their device not having been reprogrammed as required, Merck Serono is recalling the current easypod device and replacing it with a new model. The newer model (model 5.2) will not proceed to injection if the cartridge in the device does not match the programmed settings. Further, this feature cannot be over-ridden by the patient representing an improvement on the cartridge recognition feature in the current model (model 5.1). |
| Recall Action |
Recall |
| Recall Action Instructions |
Merck Serono is contacting clinicians and pharmacists of patients under the PBS Growth Hormone Program for replacing the Easypod auto injector model 5.1 with model 5.2. Merck Serono is contacting private patients affected and asking them to get the replacement devices from their pharmacies. In the meantime, customers are asked not to stop using SAIZEN and continue with the treatment as directed by their doctor. For more details, please see http://www.tga.gov.au/safety/alerts-device-easypod-auto-injector-130906.htm . |
| Contact Information |
1800 682 536 - Merck Serono Australia |