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U.S. Department of Health and Human Services

Class 3 Device Recall 7 cm Catheter Reservoir with 10 cm extension

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 Class 3 Device Recall 7 cm Catheter Reservoir with 10 cm extensionsee related information
Date Initiated by FirmMarch 24, 2005
Date PostedJanuary 10, 2006
Recall Status1 Terminated 3 on January 10, 2006
Recall NumberZ-0366-06
Recall Event ID 32533
510(K)NumberK853361 K853362 
Product Classification Catheter, Ventricular - Product Code HCA
Product7 cm Catheter Reservoir with 10 cm extension
Code Information M1330/PR07X/11-2009 and M1476/PR07X/12-2009
FEI Number 2518608
Recalling Firm/
Manufacturer		 Vygon Neuro
2495 General Armistead Ave
Norristown PA 19403-3685
For Additional Information ContactCourtney Smith
610-539-9300
Manufacturer Reason
for Recall		stylet in package is shorter than that claimed on the label
FDA Determined
Cause 2		Other
ActionThe recalling firm issued a letter to their customers informing them of the problem and the need to return the product.
Quantity in Commerce11 units
DistributionThe product was shipped to a hospital in CA and a distributor in 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.
510(K) Database510(K)s with Product Code = HCA
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