Public recall detail

Gelita Tuft-It®

2022-09-23

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Recall Safety notice
Quick summary

Quick summary: Gelita Tuft-It®. Date: 2022-09-23.

Recommended action

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

Recall details

Quick summary: Gelita Tuft-It®. Date: 2022-09-23.

Official details

Affected product details

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

BrandGelita Medical Gmbh
ProductGelita Tuft-It®
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64567

Affected products

ProductGelita Tuft-It®
LotF00080/1 F00077/1 F00079/1 F00116/2
ModelGF-7365
Serial numberF00080/1 F00077/1 F00079/1 F00116/2
DescriptionGelita Tuft-It®

Issue

The endotoxin limit/specification appears to have been exceeded in re-testing using a new method. Recall start date: September 9, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesGelita Medical GmbH Uferstrasse 7, Eberbach, Germany, 69412
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64567
Background{}
CompaniesGelita Medical GmbH Uferstrasse 7, Eberbach, Germany, 69412
AudiencesGeneral public Healthcare Industry
Source updated2022-09-23

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

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