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Class 2 Device Recall ACS |
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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
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Product Classification |
Hemostatic Valve - Product Code DTL
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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
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For Additional Information Contact |
Janet Benson 951-914-2921
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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
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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
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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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510(K) Database |
510(K)s with Product Code = DTL and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.
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