Public recall detail

Codman Bactiseal EVD Catheter Set

2024-05-29

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Recall Safety notice
Quick summary

Quick summary: Codman Bactiseal EVD Catheter Set. Date: 2024-05-29.

Recommended action

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

Recall details

Quick summary: Codman Bactiseal EVD Catheter Set. Date: 2024-05-29.

Official details

Affected product details

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

BrandIntegra Lifesciences Production Corporation
ProductCodman Bactiseal EVD Catheter Set
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-75577

Affected products

ProductCodman Bactiseal EVD Catheter Set
Lot7322926 7322939 7322933 7314916 7322927 7322941
Model82-1745 82-1750 82-1749
Serial number7322926 7322939 7322933 7314916 7322927 7322941
DescriptionCodman Bactiseal EVD Catheter Set

Issue

The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the sealing. There is no issue with the inner sterile packaging (tray). However, even if the inner packaging (tray) is sealed correctly, the defect in the outer sterile packaging (pouch) could lead to cross contamination during handling. Recall start date: May 16, 2024

What you should do

  • Contact manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesIntegra Lifesciences Production Corporation 11 Cabot Blvd., Mansfield, Massachusetts, United States, 02048
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75577
Background{}
CompaniesIntegra Lifesciences Production Corporation 11 Cabot Blvd., Mansfield, Massachusetts, United States, 02048
AudiencesHealthcare
Source updated2024-05-29

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

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