Public recall detail

Electrode Profonde

2021-12-21

medium
Recall Safety notice
Quick summary

Quick summary: Electrode Profonde. Date: 2021-12-21.

Recommended action

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

Recall details

Quick summary: Electrode Profonde. Date: 2021-12-21.

Official details

Affected product details

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

BrandDixi Medical
ProductElectrode Profonde
IssueMedical devices - Manufacturing defect
Recall classType II
IdentificationRA-63753

Affected products

ProductElectrode Profonde
LotAll lots.
ModelD08-08AT, D08-08AM, D08-15AT, D08-18ATM, D08-05AM, D08-05AT, D08-18CM, D08-12AT, D08-10AT, D08-12AM, D08-15BM, D08-18AT
Serial numberAll lots.
DescriptionElectrode Profonde

Issue

Detection of a deformation in the blister pack of the primary packaging during a production control which could lead to a perforation. Secondary packaging is not affected. Recall start date: Nov 19, 2021

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Neurology
CompaniesDixi Medical 2a Route De Pouligney Chaudefontaine, Marchaux-Chaudefontaine France, 25640
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63753
Background{}
CompaniesDixi Medical 2a Route De Pouligney Chaudefontaine, Marchaux-Chaudefontaine France, 25640
AudiencesGeneral public Health professionals Hospitals
Source updated2021-12-21

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

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