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U.S. Department of Health and Human Services

Class 2 Device Recall ACS

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  Class 2 Device Recall ACS see related information
Date Initiated by Firm December 05, 2006
Date Posted February 01, 2007
Recall Status1 Terminated 3 on July 24, 2012
Recall Number Z-0392-2007
Recall Event ID 37019
510(K)Number K934624  
Product Classification Hemostatic Valve - Product Code DTL
Product ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245
Code Information 6090651, 6090652 , 6090653
Recalling Firm/
Manufacturer		 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Janet Benson
951-914-2921
Manufacturer Reason
for Recall		 Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch
FDA Determined
Cause 2		 Other
Action On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented.
Quantity in Commerce 6090651 - 346 devices, 6090652 - 395 devices, 6090653 - 315 devices
Distribution Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.
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 = DTL and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.
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