Public recall detail

Tracoe Experc Sets

2023-02-22

medium
Recall Safety notice
Quick summary

Quick summary: Tracoe Experc Sets. Date: 2023-02-22.

Recommended action

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

Recall details

Quick summary: Tracoe Experc Sets. Date: 2023-02-22.

Official details

Affected product details

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

BrandTracoe Medical GmbH
ProductTracoe Experc Sets
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-72899

Affected products

ProductTracoe Experc Set Vario
Lot0008-1000201978 1100005364 1100016281 1100014041 0008-1000201989 1100000667 1100014802
Model424-08 423-08 423-07
Serial number0008-1000201978 1100005364 1100016281 1100014041 0008-1000201989 1100000667 1100014802
DescriptionTracoe Experc Set Vario
ProductTracoe Experc Set Twist
Lot1100009040 1100005139
Model322-08
Serial number1100009040 1100005139
DescriptionTracoe Experc Set Twist

Issue

It was discovered that the Instructions for Use (IFU) of the Tracoe Experc dilation set, ref 520, has not been included in the product scope of the Tracoe Experc sets for Vario, Twist and Twist Plus. Recall start date: February 01, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesTracoe Medical GmbH Reichelsheimer Str.1/3, Nieder-Olm, Germany, 55268
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72899
Background{}
CompaniesTracoe Medical GmbH Reichelsheimer Str.1/3, Nieder-Olm, Germany, 55268
AudiencesHealthcare
Source updated2023-02-22

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

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