Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Codman

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Codman see related information
Date Initiated by Firm October 25, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on May 29, 2015
Recall Number Z-0707-2012
Recall Event ID 60362
510(K)Number K914479  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
Product 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.
Code Information Lot codes: 091D1357 09AD4024 09DD3119 09FD2303  09GD1485  09HD0439  09JD0410  09JD3907  09KD2828  09LD2187 10AD2613  l0BD2115  10CD3938 10FD0538 10GD0534 10ID1319 10lD5075 10JD2337  l0JD3344 10JD4027  l0KD0816 10LD1062 10LD3169 11BD0122 11BD3275 11FD0392 l1FD0648 11GD3385 11HD1641  
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 13845 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = Codman & Shurtleff, Inc.
-
-