Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P
FDA device recall Z-1422-2010 · posted 2010-04-20 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
- Action taken
- An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 1
- Distribution
- One hospital in Omaha, NE.
- Date initiated
- 2010-02-18
- Date posted
- 2010-04-20
- Date terminated
- 2010-04-20
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LICOX PMO BRAIN MONITORING SYSTEM (K040235) | Integra LifeSciences Corporation | 2004-04-20 |