Public recall detail

Hls Set Advanced 5.0 and 7.0 With Bioline Coating

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Recall Safety notice
Quick summary

Quick summary: Hls Set Advanced 5.0 and 7.0 With Bioline Coating.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Hls Set Advanced 5.0 and 7.0 With Bioline Coating.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMaquet Cardiopulmonary Gmbh
ProductHls Set Advanced 5.0 and 7.0 With Bioline Coating
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-64399

Affected products

ProductHls Set Advanced 7.0 With Bioline Coating
Lot3000233773 3000233810
Model701069065 BEQ-HLS 7050-CA
Serial number3000233773 3000233810
DescriptionHls Set Advanced 7.0 With Bioline Coating
ProductHls Set Advanced 5.0 With Bioline Coating
Lot3000219510
Model701069068 BEQ-HLS 5050-CA
Serial number3000219510
DescriptionHls Set Advanced 5.0 With Bioline Coating

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt, Germany, 76437
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64399
Background{}
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt, Germany, 76437
AudiencesHealthcare
Source updated2022-07-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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