Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
This recall has been terminated (originally issued April 20, 2010).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- February 18, 2010
- Posted
- April 20, 2010
- Terminated
- April 20, 2010
- Recall Number
- Z-1422-2010
- Quantity
- 1
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
Distribution
One hospital in Omaha, NE.
Lot / Code Info
Catalog number CC1P1, Serial number SN 776; Lot number 160110A
Root Cause
Process control
Action Taken
An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.