Recall Z-0707-2012 ยท GWM Device, Monitoring, Intracranial Pressure
Codman & Shurtleff, Inc.
Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 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.
| Date | Jan 11, 2012 (initiated Oct 25, 2011) |
| Status | Terminated |
| Reason | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 13845 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER Codman & Shurtleff, Inc., Mar 7, 1994 |