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/ Manufacturer |
Symbiosis Corp. 8600 NW 41th Street Miami FL 33166
|
For Additional Information Contact |
James Twitchell 305-597-4287
|
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 |
Other |
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
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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.
|
510(K) Database |
510(K)s with Product Code = DQX and Original Applicant = BOSTON SCIENTIFIC CORP.
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