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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific

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  Class 3 Device Recall Boston Scientific see related information
Date Initiated by Firm November 27, 2002
Date Posted March 20, 2003
Recall Status1 Terminated 3 on July 13, 2012
Recall Number Z-0666-03
Recall Event ID 25704
510(K)Number K933334  
Product Classification Wire, Guide, Catheter - Product Code DQX
Product Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
Code Information Pouch codes for the 180 cm length wuidewires are:  Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 ''  The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''
Recalling Firm/
Symbiosis Corp.
8600 NW 41th Street
Miami FL 33166
For Additional Information Contact James Twitchell
Manufacturer Reason
for Recall
The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
FDA Determined
Cause 2
Action A Recall Notification Letter was send to hospitals via Federal Express Overnight Delivery, on 11/27/2002 to the attention of the Risk Manager and the Cath Lab Manager. In addition a response form was included. Recalled units are to be returned to the Boston Scientific Distribution Center located at 500 Commander Shea Blvd., Quincy, MA 02171.
Quantity in Commerce 286
Distribution Product was distributed to 118 hospitals nationwide.
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 = DQX and Original Applicant = BOSTON SCIENTIFIC CORP.