Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0061-2014·Announced 2013-10-30

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Integra LifeSciences Corp.
Category: Medical Device — Neurological Monitoring
Hazard: defective-component
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.

See all 10 products in this recall →

Same manufacturer · Integra LifeSciences Corp.

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