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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott Vascular 6F Viking Guiding Catheter, Shape ALR 1.2

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 Class 3 Recall
Abbott Vascular 6F Viking Guiding Catheter, Shape ALR 1.2
see related information
Date Posted August 13, 2008
Recall Status1 Open
Recall Number Z-1633-2008
Recall Event ID 47361
Premarket Notification
510(K) Number
K972484 
Product Classification Catheter, Percutaneous - Product Code DQY
Product 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introduced.
Code Information Lot Number: 8011791
Recalling Firm/
Manufacturer
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula, California 92591-4630
For Additional Information Contact Phil Russ
951-914-1123
Manufacturer Reason
for Recall
Mislabeling: The part number on the product label packaging may not match the product.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.
Quantity in Commerce 10 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = GUIDANT CORP.
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