Official recall record
Codman Bactiseal EVD Catheter Set
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-05-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.