Hls Set Advanced 5.0 and 7.0 With Bioline Coating
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Hls Set Advanced 7.0 With Bioline Coating |
3000233773 |
701069065 BEQ-HLS 7050-CA |
Hls Set Advanced 5.0 With Bioline Coating |
3000219510 |
701069068 BEQ-HLS 5050-CA |
Issue
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.
Additional information
Details
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
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