Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.
Recall
- Recall Number
- Z-0706-2012
- Event Number
- 60362
- Firm
- Codman & Shurtleff, Inc.
- FEI Number
- 3002947440
- Product Code
- GWM
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- October 25, 2011
- Posted
- January 11, 2012
- Terminated
- May 29, 2015
- Address
- 325 Paramount Drive, Raynham, MA, 02767
Description
Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.
Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
861 units