| Class 3 Device Recall Boston Scientific Guider Softip XF Guiding Catheter | |
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
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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/ Manufacturer |
Boston Scientific Target 47900 Bayside Pkwy Fremont CA 94538-6515
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For Additional Information Contact | 510-440-7700 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQY
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