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U.S. Department of Health and Human Services

Class 2 Device Recall Navigator HD

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  Class 2 Device Recall Navigator HD see related information
Date Initiated by Firm November 05, 2013
Date Posted December 04, 2013
Recall Status1 Terminated 3 on December 08, 2014
Recall Number Z-0440-2014
Recall Event ID 66828
Product Classification endoscopic access overtube, gastroenterology-urology - Product Code FED
Product Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile.

Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Code Information UPN M0062502270, Catalog 250-227, Lot 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213 , 15896950, 15935564, 16028474, 16044445, and 16046280
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Brent Hathcock
763-494-1133
Manufacturer Reason
for Recall		 The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
FDA Determined
Cause 2		 Component design/selection
Action Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.
Quantity in Commerce 274
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.
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.
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