HLS Set Advanced Bioline Coating
Brand(s)
Last updated
Summary
Product
HLS Set Advanced Bioline Coating
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| HLS Set Advanced Bioline Coating | 3000183179 3000183910 3000183908 3000183172 3000183191 3000184681 | 70105-2794 BEQ-HLS 7050-USA 70105.2797 BEQ-HLS 5050-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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Maquet Cardiopulmonary GmbH
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64395
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