Date Initiated by Firm |
November 30, 2007 |
Date Posted |
April 30, 2008 |
Recall Status1 |
Terminated 3 on October 22, 2008 |
Recall Number |
Z-0913-2008 |
Recall Event ID |
46330 |
510(K)Number |
K061009
|
Product Classification |
Ureteral dilator - Product Code EZN
|
Product |
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760 |
Code Information |
Lot Number: W03-2341, W03-2357, W03-2395, W03-2578 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 500 Commander Shea Blvd Quincy MA 02171-1518
|
For Additional Information Contact |
Robert T. Miragliuolo 508-683-4186
|
Manufacturer Reason for Recall |
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
|
FDA Determined Cause 2 |
Device Design |
Action |
Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form. |
Quantity in Commerce |
190 |
Distribution |
Nationwide Distribution |
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 = EZN and Original Applicant = ONSET MEDICAL CORPORATION
|