On behalf of the B. Braun Hospicare Ltd. the MHRA hereby recall the following products which have been distributed in the UK in the context of a FIELD SAFETY CORRECTIVE ACTION from the market:
|Article Number||Article Name||Batch|
|001419N||ASKINA GEL 156||ALL|
|0014195||ASKINA GEL 156||ALL|
|6241505||ASKINA CALGITROL PASTE 15 G||ALL|
Reason for the Recall
In the manufacturing site it was determined that the irradiation dose qualified for sterilization of the above mentioned products was too low. In consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 1o-e. The effect cannot be limited to specific batches.
Up to now no market feedback has been received on any adverse patient outcome which could be associated to the above described observation. However, it has been decided to recall the affected products from the market as a preventive measure.