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U.S. Department of Health and Human Services

Class 3 Device Recall 10 cm Scopable Catheter Reservoir

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  Class 3 Device Recall 10 cm Scopable Catheter Reservoir see related information
Date Initiated by Firm March 24, 2005
Date Posted January 10, 2006
Recall Status1 Terminated 3 on January 10, 2006
Recall Number Z-0367-06
Recall Event ID 32533
510(K)Number K853361  K853362  
Product Classification Catheter, Ventricular - Product Code HCA
Product 10 cm Scopable Catheter Reservoir
Code Information N0297/SRS10/03-2009
Recalling Firm/
Manufacturer		 Vygon Neuro
2495 General Armistead Ave
Norristown PA 19403-3685
For Additional Information Contact Courtney Smith
610-539-9300
Manufacturer Reason
for Recall		 stylet in package is shorter than that claimed on the label
FDA Determined
Cause 2		 Other
Action The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.
Quantity in Commerce 14 units
Distribution The product was shipped to a hospital in CA and a distributor in Germany.
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 = HCA and Original Applicant = HOLTER-HAUSNER INTL.
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