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Hls set advanced bioline coating
Official notice
25 Jul 2022
Last checked
25 Jul 2022
An official Health Canada notice concerns Hls set advanced bioline coating. 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 Published 2022-07-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64395
Official notice
2022-07-25
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Maquet Cardiopulmonary, Hls Set Advanced Bioline Coating.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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