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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall Abbott Vascular 6F Viking Guiding Catheter, Shape BPL see related information
Date Initiated by Firm March 17, 2008
Date Posted August 13, 2008
Recall Status1 Terminated 3 on July 07, 2011
Recall Number Z-1634-2008
Recall Event ID 47361
510(K)Number K972484  
Product Classification Catheter - Product Code DQY
Product 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054.

Intended to provide a pathway through 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 CA 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		 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 7 units
Distribution Nationwide Distribution.
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 = DQY and Original Applicant = GUIDANT CORP.
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