Integra Lifesciences’ Codman Microsensor Basic Kit for Subdural/Intraparenchymal Procedure (model 626631, lot 7411808) and CereLink ICP Sensor Basic Kit for Subdural/Intraparenchymal Procedure (model 826850; multiple lot/serial numbers—contact manufacturer for specifics) are affected. They were recalled because certain released lots may have corrosion stains on the surface of the 14‑gauge tuohy needle included in the kits. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Integra Lifesciences Production Corporation, 11 Cabot Blvd., Mansfield, Massachusetts, United States, 02048.
How to identify it
Affected products: Codman Microsensor Basic Kit For Subdural/ Intraparenchymal Procedure; Lot or serial number: 7411808; Model or catalogue number: 626631
Affected products: Cerelink ICP Sensor Basic Kit For Subdural/Intraparenchymal Procedure; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 826850
The hazard
During an investigation, Integra Lifesciences identified lots that were released with potential corrosion stains on the surface of the 14-gauge tuohy needle that is included in the Codman Microsensor® Basic Kits 626631 and CereLink™ ICP Sensor Basic Kits 826850
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)