FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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.
- Recall number
- Z-1422-2010
- Recalling firm
- Integra LifeSciences Corp.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-02-18
- Posted
- 2010-04-20
- Terminated
- 2010-04-20
- Reason
- One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
- Root cause
- Process control
- Action
- An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
- Quantity
- 1
- Distribution
- One hospital in Omaha, NE.
- Lot, serial or model codes
- Catalog number CC1P1, Serial number SN 776; Lot number 160110A
- 510(k) numbers
- ["K040235"]
- PMA numbers
- not on file
- Product code
- GWM
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28