Date Initiated by Firm |
March 17, 2008 |
Date Posted |
August 13, 2008 |
Recall Status1 |
Terminated 3 on July 07, 2011 |
Recall Number |
Z-1633-2008 |
Recall Event ID |
47361 |
510(K)Number |
K972484
|
Product Classification |
Catheter - 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 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 |
10 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.
|