Codman Bactiseal EVD Catheter Set
Summary
Contact manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
---|---|---|
Codman Bactiseal EVD Catheter Set |
7322926 |
82-1745 |
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
Integra Lifesciences Production Corporation |
11 Cabot Blvd., Mansfield, Massachusetts, United States, 02048 |
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