Public recall detail

Excor System Cannulas

2023-08-17

medium
Recall Safety notice
Quick summary

Quick summary: Excor System Cannulas. Date: 2023-08-17.

Recommended action

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

Recall details

Quick summary: Excor System Cannulas. Date: 2023-08-17.

Official details

Affected product details

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

BrandBerlin Heart Gmbh
ProductExcor System Cannulas
IssueMedical devices - Performance
Recall classType I
IdentificationRA-74133

Affected products

ProductExcor System - Apex Cannulas
LotAll lots.
ModelC14A-040M C18A-020 C22A-004 C27A-001
Serial numberAll lots.
DescriptionExcor System - Apex Cannulas
ProductExcor System - Atrial Cannulas
LotAll lots.
ModelC15V-040M C23V-004 C25V-004 C22V-002M C19V-020M C22V-004
Serial numberAll lots.
DescriptionExcor System - Atrial Cannulas
ProductExcor System - Arterial Cannulas
LotAll lots.
ModelC60G-002M C85G-004 C80G-040M C85G-002M C60G-004M C80G-021M
Serial numberAll lots.
DescriptionExcor System - Arterial Cannulas
ProductExcor System - Connecting Set For Cannulas
LotAll lots.
ModelA06-009 A09-012
Serial numberAll lots.
DescriptionExcor System - Connecting Set For Cannulas

Issue

The purpose of the urgent medical device correction notification is to advise healthcare professionals that Berlin Heart is conducting a voluntary correction concerning all Excor cannulae due to the potential of partial or complete breaches of an Excor cannula. A significant cannula breach may result in massive blood loss and/or an air embolism which could result in blood loss and/or death to the patient. No product will be removed. Recall Start Date: August 4, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesBerlin Heart gmbh Wiesenweg 10, Berlin, Germany, 12247
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-74133
Background{}
CompaniesBerlin Heart gmbh Wiesenweg 10, Berlin, Germany, 12247
AudiencesHealthcare
Source updated2023-08-17

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

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