Date Initiated by Firm |
June 02, 2010 |
Date Posted |
February 09, 2011 |
Recall Status1 |
Terminated 3 on February 09, 2011 |
Recall Number |
Z-1092-2011 |
Recall Event ID |
56391 |
Product Classification |
VAD access tray - Product Code LRS
|
Product |
Centurion Medical Products VAD access tray HT2440A, Sterile |
Code Information |
2009102250 and 2009100950 |
Recalling Firm/ Manufacturer |
Centurion Medical Products 301 Catrell Dr Howell MI 48843-1703
|
For Additional Information Contact |
Matthew Price 517-546-5400
|
Manufacturer Reason for Recall |
The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved. |
Quantity in Commerce |
96 |
Distribution |
Nationwide distribution. |
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.
|