Health product recall

Codman Bactiseal EVD Catheter Set

Last updated

Summary

Product
Codman Bactiseal EVD Catheter Set
Issue
Medical devices - Sterility Issue
What to do

Contact manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Codman Bactiseal EVD Catheter Set

7322926
7322939
7322933
7314916
7322927
7322941

82-1745
82-1750
82-1749

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Integra Lifesciences Production Corporation
11 Cabot Blvd., Mansfield, Massachusetts, United States, 02048
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75577

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