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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 Recall
Boston Scientific Guider Softip XF Guiding Catheter
see related information
Date Posted November 24, 2007
Recall Status1 Terminated on December 05, 2007
Recall Number Z-0259-2008
Recall Event ID 38445
Premarket Notification
510(K) Number
K980453 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
Code Information LOT 9311885, Catalogue #10042, Material #H965100420, Expires 10-JAN-2010
Recalling Firm/
Manufacturer
Boston Scientific Target
47900 Bayside Pkwy
Fremont, California 94538-6515
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
Quantity in Commerce 47 units
Distribution Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
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 = BOSTON SCIENTIFIC SCIMED, INC.
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