Date Initiated by Firm |
June 02, 2005 |
Date Posted |
July 07, 2005 |
Recall Status1 |
Terminated 3 on December 13, 2006 |
Recall Number |
Z-0967-05 |
Recall Event ID |
32383 |
510(K)Number |
K031538
|
Product Classification |
Tubes, Gastrointestinal (And Accessories) - Product Code KNT
|
Product |
Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838. |
Code Information |
Lots 7452729, 7448186, 7426909 and 7385202. |
Recalling Firm/ Manufacturer |
Boston Scientific Corp 780 Brookside Dr Spencer IN 47460-1080
|
For Additional Information Contact |
Kathy Thorp 508-683-4026
|
Manufacturer Reason for Recall |
Two blades may be heat staked onto the stiletto instead of the expected one blade.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand. |
Distribution |
Nationwide and Panama. |
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 = KNT and Original Applicant = BOSTON SCIENTIFIC CORP.
|