LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, New Jersey 08536 USA. Used for continuous determination of oxygen partial pressure in cerebrospinal fluid and brain tissue.
This recall has been terminated (originally issued March 3, 2011).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- December 17, 2010
- Posted
- March 3, 2011
- Terminated
- November 5, 2012
- Recall Number
- Z-1518-2011
- Quantity
- 26 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
Distribution
Worldwide Distribution
Lot / Code Info
Lot/Serial numbers: 1982, 1988, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2003, 2005, 2007, 2008, 2009, 2010, 2011, 2012, 2014, 2046, 2047, 2051, and 2053.
Root Cause
Nonconforming Material/Component
Action Taken
Integra Life Sciences notified their Integra Neurospecialist via email and their customers via Fed Ex overnight mail on December 17, 2010 with an Urgent: Product Recall letter. The letter identified the affected product and the reason for the recall. The letter states that an Integra Neurospecialist will contact customers to arrange for the return of their Licox monitor to the Service Center for recalibration. A loaner will be provided until the recalibration is complete. The attached "Recall Acknowledgement and Return Form" must be completed and returned to Integra. If there are any additional questions, customers should contact Gary Rabinovich at 609-936-6864.