Date Initiated by Firm |
May 05, 2004 |
Date Posted |
March 10, 2005 |
Recall Status1 |
Terminated 3 on November 21, 2008 |
Recall Number |
Z-0588-05 |
Recall Event ID |
29574 |
510(K)Number |
K001136
|
Product Classification |
Catheter, Percutaneous - Product Code DQY
|
Product |
Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S |
Code Information |
Lot # L0104244 |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 NW 60th Ave Miami Lakes FL 33014-2802
|
Manufacturer Reason for Recall |
The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
|
FDA Determined Cause 2 |
Other |
Action |
A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion. |
Quantity in Commerce |
40 |
Distribution |
Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa 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.
|
510(K) Database |
510(K)s with Product Code = DQY and Original Applicant = CORDIS CORP.
|