Public recall detail

Zenith Branch Endovascular Graft Iliac Bifurcation

2023-03-30

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Recall Safety notice
Quick summary

Quick summary: Zenith Branch Endovascular Graft Iliac Bifurcation. Date: 2023-03-30.

Recommended action

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

Recall details

Quick summary: Zenith Branch Endovascular Graft Iliac Bifurcation. Date: 2023-03-30.

Official details

Affected product details

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

BrandWilliam A. Cook Australia, Pty. Ltd.
ProductZenith Branch Endovascular Graft Iliac Bifurcation
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73410

Affected products

ProductZenith Branch Endovascular Graft Iliac Bifurcation
LotAll lots.
ModelZBIS-12-45-41 ZBIS-12-61-58 ZBIS-10-45-41 ZBIS-10-45-58 ZBIS-12-45-58 ZBIS-12-61-41
Serial numberAll lots.
DescriptionZenith Branch Endovascular Graft Iliac Bifurcation

Issue

Tip of the catheter, which is an indwelling component of the Zenith Branch Iliac Endovascular (ZBIS) and the Bifurcated Iliac sidebranch CMD can split / break during device preparation or during the endovascular procedure. This recall is specific to all lots manufactured prior to March 8, 2023. Recall start date: March 23, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesWilliam A. Cook Australia, Pty. Ltd. 95 Brandl Street, Queensland, Australia, 4113
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73410
Background{}
CompaniesWilliam A. Cook Australia, Pty. Ltd. 95 Brandl Street, Queensland, Australia, 4113
AudiencesHealthcare
Source updated2023-03-30

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

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