Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellsc
FDA device recall Z-0058-2014 · posted 2013-10-23 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Action taken
- Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 175 KITS
- Distribution
- 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.
- Date initiated
- 2013-06-11
- Date posted
- 2013-10-23
- Date terminated
- 2014-02-18
- Location
- Plainsboro, NJ
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