LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik
FDA device recall Z-1518-2011 · posted 2011-03-03 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 26 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2010-12-17
- Date posted
- 2011-03-03
- Date terminated
- 2012-11-05
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE (K002765) | Integra Neurosciences | 2000-11-24 |