CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen recalled
Integra LifeSciences is recalling Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit, distributed nationwide in the US. The recall was initiated on 11 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0060-2014
- FDA event ID
- 65742
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2013
- FDA classified
- 23 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jun 2013 | Recall initiated by company | |
| 23 Oct 2013 | Classified by FDA | +134 days |
| 30 Oct 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Where it was distributed
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Questions about this recall
Is Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit recalled?
Yes. Integra LifeSciences recalled Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit on 11 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-0060-2014.
Why was it recalled?
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.
Which lots are affected?
Lot # 010612, 140512, 140612
Where was it sold?
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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