Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Pediatric Product Code:80-1197 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.
FDA Recall Z-0710-2012 · Posted 2012-01-11
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Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeGWM
Date Initiated2011-10-25
Date Terminated2015-05-29
Product Quantity254 units
Reason for Recall
Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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