Public recall detail

Tornado, Nestor and Hilal Embolization Microcoils

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Recall Safety notice
Quick summary

Quick summary: Tornado, Nestor and Hilal Embolization Microcoils.

Recommended action

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

Recall details

Quick summary: Tornado, Nestor and Hilal Embolization Microcoils.

Official details

Affected product details

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

BrandCook, Inc.
ProductTornado, Nestor and Hilal Embolization Microcoils
IssueMedical devices - Performance Medical devices - Sterility
Recall classType II
IdentificationRA-64203

Affected products

ProductAffected products
LotLot or serial number
ModelModel or catalog number
Serial numberLot or serial number
DescriptionAffected products
ProductTornado Embolization Microcoils
LotMore than 10 numbers, contact manufacturer.
ModelMWCE-18S-6/2-TORNADO-01 MWCE-18S-3/2-TORNADO-01 MWCE-18S-6/2-TORNADO MWCE-18S-4/2-TORNADO-01 MWCE-18S-5/2-TORNADO-01
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTornado Embolization Microcoils
ProductNestor Plantinum Embolization Coi
LotMore than 10 numbers, contact manufacturer.
ModelMWCE-18-7-10-NESTER MWCE-18-7-3-NESTER MWCE-18-5-2-NESTER MWCE-18-3-2-NESTER MWCE-18-7-2-NESTER MWCE-18-7-5-NESTER
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNestor Plantinum Embolization Coi
ProductHilal Embolization Microcoils
LotMore than 10 numbers, contact manufacturer.
ModelMWCE-18-0.5-0-HILAL-01
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHilal Embolization Microcoils
ProductNestor Embolization Microcoils
LotMore than 10 numbers, contact manufacturer.
ModelMWCE-18-3-3-NESTER-01 MWCE-18-5-3-NESTER-01 MWCE-18-7-3-NESTER-01 MWCE-18-2-2-NESTER-01 MWCE-18-3-2-NESTER-01 MWCE-18-7-4-NESTER-01 MWCE-18-7-8-NESTER-01 MWCE-18-5-2-NESTER-01 MWCE-18-7-5-NESTER-01 MWCE-18-7-2-NESTER-01 MWCE-18-7-6-NESTER-01 MWCE-18-5-5-NESTER-01
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNestor Embolization Microcoils

Issue

Cook Medical identified during manufacturing that an unintended small stainless-steel cannula may be contained in the loading cartridge of these devices. This loading cartridge is manufactured by an external supplier. Recall start date: May 6, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular Health products - Medical devices - Neurology
CompaniesCook, Inc. 750 Daniels Way, Bloomington, Indiana, United States, 47404
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64203
Background{}
CompaniesCook, Inc. 750 Daniels Way, Bloomington, Indiana, United States, 47404
AudiencesHealthcare
Source updated2022-05-30

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

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