Date Initiated by Firm |
July 01, 2003 |
Date Posted |
August 12, 2003 |
Recall Status1 |
Terminated 3 on December 28, 2006 |
Recall Number |
Z-1115-03 |
Recall Event ID |
26708 |
510(K)Number |
K021735
|
Product Classification |
unknown device name - Product Code GBR
|
Product |
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015
, Product Number H7493791540150
|
Code Information |
Lot number 5562834 |
Recalling Firm/ Manufacturer |
Boston Scientific Scimed One Scimed Place Maple Grove MN 55311-1566
|
For Additional Information Contact |
Patrick Burt 763-494-1192
|
Manufacturer Reason for Recall |
Some of the product pouches have holes in the seals.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them. |
Quantity in Commerce |
3 |
Distribution |
The recalled products were shipped to hospitals located nationwide in the United States. |
|
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 = GBR and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
|