Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may not 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. The hazard involves a functional defect in a medical device component (hex wrench) that could impede proper use, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corporation has initiated a recall of Licox Brain Tissue Oxygen and Temperature Catheter Kits. The company determined that there is a possibility that some lots of these 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 Complete Brain Probe Kit (REF IM3.SR), manufactured by GMS- Gesellschaft fur medizinische Sondentechnik mbH and distributed by Integra Neurosciences. The recall involves 175 kits distributed worldwide, including the United States and various international markets. Specific lot numbers are listed in the agency's structured data.
Healthcare providers and consumers should stop using the affected kits and contact the recalling firm for instructions on return or replacement. This 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 adverse health consequences.
The recalled product
- Product
- Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR 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.
- Affected units
- 175
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 (12)
- K002765 Lot # 130712
- 210912
- 220612
- 172281
- 172647
- 172690
- 173170
- 173260
- 173548
- 173580
- 173917
- 173942
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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