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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific Guider Softip XF Guiding Catheter

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  Class 3 Device Recall Boston Scientific Guider Softip XF Guiding Catheter see related information
Date Initiated by Firm July 11, 2007
Date Posted November 24, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0260-2008
Recall Event ID 38445
510(K)Number K980453  
Product Classification Guiding Catheter - Product Code DQY
Product Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
Code Information LOT 9311878, Catalogue #10142, Material #M003101420, Expires 10-JAN-2010
Recalling Firm/
Boston Scientific Target
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
Manufacturer Reason
for Recall
Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)
FDA Determined
Cause 2
Labeling mix-ups
Action Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
Quantity in Commerce 49 units
Distribution Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
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 = BOSTON SCIENTIFIC SCIMED, INC.