Health product recall

Hls Set Advanced 5.0 and 7.0 With Bioline Coating

Last updated

Summary

Product
Hls Set Advanced 5.0 and 7.0 With 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 catalogue number
Hls Set Advanced 7.0 With Bioline Coating 3000233773 3000233810 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies

Maquet Cardiopulmonary Gmbh

Kehler Strasse 31, Rastatt, Germany, 76437

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64399