HLS Set Advanced Bioline Coating
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
HLS Set Advanced Bioline Coating |
3000183179 |
70105-2794 BEQ-HLS 7050-USA |
Issue
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
Additional information
Details
Maquet Cardiopulmonary GmbH
Kehler Strasse 31, Rastatt, Germany, 76437
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