Date Initiated by Firm |
October 25, 2011 |
Date Posted |
January 11, 2012 |
Recall Status1 |
Terminated 3 on May 29, 2015 |
Recall Number |
Z-0708-2012 |
Recall Event ID |
60362 |
510(K)Number |
K853770
|
Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
|
Product |
Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw Product Code:80-1190
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.
|
Code Information |
Lot codes: 422002 450730 456778 AB243 AC319 BA201 BA202 CB317 DB319 FB302 GA230 HA291 JZ285 KA291 LB213 LZ288 |
Recalling Firm/ Manufacturer |
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham MA 02767
|
For Additional Information Contact |
508-880-8100
|
Manufacturer Reason for Recall |
Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
|
FDA Determined Cause 2 |
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 |
2827 units |
Distribution |
Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GWM and Original Applicant = Codman & Shurtleff, Inc.
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