Medical device manufacturer, B. Braun Hospicare Ltd., has issued a medical device safety alert concerning its Askina Gel and Calgitrol Paste [Article Number: 14291, 001419N, 001419NRU, 001419S, 001419SBR, 001419SES, 001419SESCP, 001419SF, 001419SFR, 001419SRU, 6241001, 6241505, 6241505F, 6241510, 6242501, 6242501FR, 6245001].
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 10-6. The effect cannot be limited to specific batches.
According to the manufacturer, there was no market feedback on any adverse patient outcome which could be associated to the above described observation. However, the manufacturer decided to recall the affected products from the market as a preventive measure.
The affected users are asked to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 May 2018