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.
What this means for you
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, and the hazard involves a functional defect in a medical device used for brain monitoring, which poses a risk of harm if the device cannot be properly installed or adjusted, though no specific injuries are reported in the source text.
Plain-English summary
Integra LifeSciences Corporation is recalling specific lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits. The recall is due to a possibility that the included hex wrench does not loosen the set screw on the drill bit.
The affected product is the Licox Brain Tissue Oxygen Monitoring kit, specifically the 1 x Dual Lumen Introducer Kit (REF IP2). The manufacturer is GMS- Gesellschaft fur medizinische, Sondentechnik mbH, and the distributor is Integra Neurosciences. A total of 62 kits were distributed, with 31 in the United States and 31 in non-US 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.
Healthcare providers and patients should stop using the affected kits and contact Integra LifeSciences for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 0853
- Manufacturer
- Integra LifeSciences Corp.
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 (8)
- K040235 Lot #020712
- 040912
- 050712
- 080612
- 110912
- 120912
- 140612
- 290812
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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