The abovementioned product is not defective and is not being recalled.
Product: MiniMed Paradigm Series Insulin Pumps when using the corresponding MiniMed Remote Controller
Sponsor: Medtronic Australasia Pty Ltd
Safety alerts are issued to provide information on the safe use of therapeutic goods in certain situations where, although meeting all specifications and therapeutic indications, its use could present an unreasonable risk of harm if certain specified precautions are not followed.
A safety alert is generally used for reiterating specific precautions or instructions regarding use of the goods.
The attached Safety Alert letter has been dispatched to those customers who have received these products.