Codman Cerelink Icp Sensor Basic Kit. Catalog Number: 826850. The Codman Cerelink Icp Sensor Basic Kit Consists Of The Cerelink Icp Sensor (icp Sensor) And A 14-gauge Tuohy Needle With Stylet. The I
Recall Summary Codman CereLink ICP Sensor Basic Kits (catalog number 826850) are being recalled due to potential corrosion stains found on the included 14-gauge Tuohy needle. These kits are used by healthcare providers to monitor intracranial pressure in patients' brains. This is a Class II recall issued by Integra LifeSciences Corp.
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is...
- Reason
- Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-12
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/92dc6d37-0db0-4114-8a86-f04c218dc02c