Public recall detail

HLS Set Advanced Bioline Coating

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Recall Safety notice
Quick summary

Quick summary: HLS Set Advanced 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 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 Bioline Coating
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-64395

Affected products

ProductHLS Set Advanced Bioline Coating
Lot3000183179 3000183910 3000183908 3000183172 3000183191 3000184681
Model70105-2794 BEQ-HLS 7050-USA 70105.2797 BEQ-HLS 5050-USA
Serial number3000183179 3000183910 3000183908 3000183172 3000183191 3000184681
DescriptionHLS Set Advanced Bioline Coating

Issue

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

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-64395
Background{}
CompaniesMaquet Cardiopulmonary GmbH Kehler Strasse 31, Rastatt, Germany, 76437
AudiencesHealthcare
Source updated2022-07-25

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