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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 FirmMarch 11, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 21, 2004
Recall NumberZ-0772-04
Recall Event ID 28678
Product Classification Catheter, Ventricular - Product Code HCA
ProductCodman Holter Salmon Rickham Reservoir with Ventricular Catheter Catalog Number: 82-1617
Code Information Lot Number: 1106525
FEI Number 3002947440
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information ContactMatthew King
508-880-8100
Manufacturer Reason
for Recall		Drainage tips absent from catheter tip
FDA Determined
Cause 2		Other
ActionCodman telephoned direct customers by telphone on 3/11/04. Accounts were requested to return product.
Quantity in Commerce39 units
DistributionCA, GA, MI, ,NC, SC, TN, TX Foreign: Italy and Germany
Total Product Life CycleTPLC 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.
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