Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Hex Wrench Defect
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some hex wrenches may fail to 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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
The recall involves 503 kits, with 482 distributed in the US and 21 distributed outside the US. The affected product is the Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit, REF IP2.P, manufactured by GMS- Gesellschaft fur medizinische, Sondentechnik mbH and distributed by Integra Neurosciences. The product is used in direct monitoring of the partial pressure of oxygen.
Affected lots include 020812l, 050712, 070612, 090812, 140612, 173419, 173438, 173515, 173538, 173540, 173720, 173725, 173887, 173918, 190712, 210612, 230812, and 260712. The recall is classified as Class II by the FDA. Healthcare providers and patients should contact the manufacturer or distributor for instructions on how to proceed with the affected kits.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.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
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 (17)
- K040235 Lot #020812l 050712
- 070612
- 090812
- 140612
- 173419
- 173438
- 173515
- 173538
- 173540
- 173720
- 173725
- 173887
- 173918
- 190712
- 210612
- 230812
- 260712
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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