Integra LifeSciences Corp.: Medical Device Recall in 2013 - (Recall #: Z-0055-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

Product Classification:

Class II

Date Initiated: June 11, 2013

Date Posted: October 30, 2013

Recall Number: Z-0055-2014

Event ID: 65742

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.

Status: Terminated

Product Quantity: 62 kits (31 US; 31 non US)

Code Information:

K040235 Lot #020712;040912;050712;080612;110912;120912;140612;290812

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated