Public recall detail

Cardiohelp-I

2022-02-28

medium
Recall Safety notice
Quick summary

Quick summary: Cardiohelp-I. Date: 2022-02-28.

Recommended action

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

Recall details

Quick summary: Cardiohelp-I. Date: 2022-02-28.

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
ProductCardiohelp-I
IssueMedical devices - Manufacturing defect
Recall classType II
IdentificationRA-63949

Affected products

ProductCardiohelp-I
Lot90414279, 90414282, 90414281, 90414303
Model70104.8012
Serial number90414279, 90414282, 90414281, 90414303
DescriptionCardiohelp-I

Issue

Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the drive during inter/intra-hospital transportation if no sprinter cart/ sprinter cart xl is used. The detected nonconformity is restricted only to transport guards distributed with specific serial numbers of Cardiohelp-I. Recall start date: Feb 22, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
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-63949
Background{}
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt Germany, 76437
AudiencesGeneral public Health professionals Hospitals
Source updated2022-02-28

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

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