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Hls set advanced 5.0 and 7.0 with bioline coating
Official notice
25 Jul 2022
Last checked
25 Jul 2022
An official Health Canada notice concerns Hls set advanced 5.0 and 7.0 with bioline coating. Maquet Cardiopulmonary Gmbh (MCP) has received customer complaints of damage to the primary packaging of the Hls Set Advanced. In all it was reported that the Tyvek cover was damaged. Investigation suggest that the Tyvek damage only occurs if the set drops upside down so either the velcro straps, holding the Hls modules, come loose or the Hls module detaches. A shift of the Hls module may cause the venous probe tab(s) to perforate the Tyvek cover. Possible sterility compromise. Recall start date: July 18, 2022. Published 2022-07-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64399
Official notice
2022-07-25
The hazard
The hazard
Maquet Cardiopulmonary Gmbh (MCP) has received customer complaints of damage to the primary packaging of the Hls Set Advanced. In all it was reported that the Tyvek cover was damaged. Investigation suggest that the Tyvek damage only occurs if the set drops upside down so either the velcro straps, holding the Hls modules, come loose or the Hls module detaches. A shift of the Hls module may cause the venous probe tab(s) to perforate the Tyvek cover. Possible sterility compromise. 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.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Maquet Cardiopulmonary, Hls Set Advanced 5.0 And 7.0 With Bioline Coating.
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Documents, notices & source
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