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U.S. Department of Health and Human Services

Class 2 Device Recall Codman

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 Class 2 Device Recall Codmansee related information
Date Initiated by FirmAugust 04, 2006
Date PostedSeptember 29, 2006
Recall Status1 Terminated 3 on April 16, 2015
Recall NumberZ-1533-06
Recall Event ID 36045
510(K)NumberK954021 
ProductCodman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
Code Information Lot Number: CGHBKY
FEI Number 3002947440
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767-5199
For Additional Information ContactMathew King
508-828-3106
Manufacturer Reason
for Recall		Sterility of device is compromised due to package seal defects
FDA Determined
Cause 2		Other
ActionCodman initiated the recall on 8/04/06 by telephone with formal follow-up fax.
Quantity in Commerce15 units
DistributionClass II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX.
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) Database510(K)s with Product Code =
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