[pending] Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Bas
Pending LLM rewrite. Source: FDA_DEVICE Z-1037-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
The recalled product
- 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 transduc
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958
- 7266691
- 7266692
- 7288060
- 7293837
- 7293836
- 7306040
- 7306041
- 7306042
- 7306043
- 7306044
- 7306045
- 7306046
- 7306047
- 7306050
- 7306051
- 7306052
- 7307670
- 7307671
- 7307672
Distribution
Distributed nationwide across the United States.
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