Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values
Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.
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 an inaccurate programmed value in a monitoring device, which is a functional defect rather than a direct physical injury risk like a structural failure or contamination. No injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 2,506 units of Licox Brain Tissue Oxygen Monitoring and Licox Recon Tissue Oxygen Monitoring products. The affected products include various Complete Brain Probe Kits and Complete Brain Tunnelling Probe Kits. These sterile, prescription-only devices are manufactured by CMS-Gesellschaft for medizinische Sondentechnik mbH and distributed by Integra NeuroSciences.
The recall was initiated after a complaint revealed that multiple lots of Licox catheters manufactured since October 29, 2013, contained a smart card programmed with an inaccurate lkN2 value. The affected lots include specific production dates for the CC1, CC12, CC1.P1, IM3ST, IP1.P, IP2.P, and IT2 product codes.
The products were distributed nationwide and to foreign markets. The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 2,506
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 (20)
- CC1 Licox¿ PO2 Microprobe
- 200 mm 021213
- 040414
- 070314
- 130114
- 240214
- 270114
- 280314
- 300614 CC12 Licox¿ PO2 Microprobe
- 300 mm 020614
- 040814
- 050514
- 070414
- 070714
- 060214
- 060314
- 100414
- 100714
- 130214
- 130314
Distribution
Distributed nationwide across the United States.
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