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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 Cathetersee related information
Date Initiated by FirmJuly 11, 2007
Date PostedNovember 24, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall NumberZ-0259-2008
Recall Event ID 38445
510(K)NumberK980453 
Product Classification Guiding Catheter - Product Code DQY
ProductBoston 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 CA 94538-6515
For Additional Information Contact
510-440-7700
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
Labeling mix-ups
ActionFirm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
Quantity in Commerce47 units
DistributionWorldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQY
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