Z-0709-2012

Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult

Name: Z-0709-2012 Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult
Creator: Codman & Shurtleff, Inc.
Published: 2011-10-25
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2011-10-25 / Terminated / root cause: labeling and UDI

FDA source

Codman & Shurtleff, Inc. began a recall of Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and... on 2011-10-25. The reason FDA records is "Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0709-2012
Status: Terminated
Initiated: 2011-10-25
Posted: 2012-01-11
Terminated: 2015-05-29
Recalling firm: Cerenovus, Inc.
Product: Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 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.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
Root cause tag: labeling and UDI
FDA 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 in commerce: 462 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
Product codes and lots: Lot codes: 449269 459957 BY254 FA247 KA209 LB283

Product code GWM

K853770Class IICodman Disposable Plastic Intracranial Press/kitCodman & Shurtleff, Inc. / cleared 1986-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)