Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some lots contain a hex wrench that may not loosen the set screw on the drill bit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a defective tool that may prevent proper assembly of the device, which is a functional defect but does not explicitly report injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Integra LifeSciences Corporation is recalling certain lots of Licox Brain Tissue Oxygen and Temperature Catheter Kits. The company determined that there is a possibility that some of these kits contain a hex wrench that does not loosen the set screw on the drill bit.
The affected product is the Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit, manufactured by GMS- Gesellschaft fur medizinische, Sondentechnik mbH and distributed by Integra Neurosciences. The recall includes 695 units distributed in the United States and foreign countries, including Argentina, Brazil, Switzerland, Chile, Costa Rica, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Mexico, Panama, Poland, Portugal, Russia, Taiwan, and South Africa. The affected lot numbers are 030912, 110612, 170812, and 230812.
Healthcare providers and facilities should stop using the affected kits and contact Integra LifeSciences for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 695
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 (4)
- Lot # 030912
- 110612
- 170812
- 230812
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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