The former packaging design of HLS set contains accessories packed in medical paper as opposed to the new introduced packaging design in Tyvek. Based on design verification tests it showed that medical paper is a weaker technical solution than Tyvek, carrying a potential risk of breaching and thus compromising the product sterility. Therefore it was decided to remove all HLS sets with former packaging design from the market. New packaging was introduced in September 2021. Recall start date: July 18, 2022
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