Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Hex Wrench Defect
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 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a mechanical component failure in a medical device used for brain monitoring, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Integra LifeSciences Corporation is recalling specific lots of Licox Brain Tissue Oxygen and Temperature Catheter Kits. The recall was initiated because the company determined there is a possibility that some kits contain a hex wrench that does not loosen the set screw on the drill bit.
The affected product is the Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit, reference IM2_EU. The manufacturer is GMS- Gesellschaft fur medizinische, Sondentechnik mbH, and the distributor is Integra Neurosciences. The recall covers 42 kits distributed in the United States and internationally in 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 010612, 140512, and 140612. These kits are used for the direct monitoring of the partial pressure of oxygen. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected kits.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_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
- 42
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 (3)
- Lot # 010612
- 140512
- 140612
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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