Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to 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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating involving a functional defect without reported harm.
Plain-English summary
Integra LifeSciences Corporation is recalling 21 kits of Licox Brain Tissue Oxygen and Temperature Catheter Kits (REF IP1.P, Lot 160812). The recall was initiated because the company determined that some lots may contain a hex wrench that does not loosen the set screw on the drill bit.
The affected products were distributed worldwide, including nationwide in the United States and in Argentina, Brazil, Switzerland, Chile, Costa Rica, Germany, Spain, Finland, France, the United Kingdom, Israel, Italy, Mexico, Panama, Poland, Portugal, Russia, Taiwan, and South Africa. The kits are used for the direct monitoring of the partial pressure of oxygen.
Healthcare facilities and consumers should stop using the affected kits and contact the recalling firm for instructions on how to return or replace the product.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 21
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 (1)
- K040235 Lot 160812
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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