Date Initiated by Firm |
April 08, 2008 |
Date Posted |
July 07, 2009 |
Recall Status1 |
Terminated 3 on November 19, 2009 |
Recall Number |
Z-1571-2009 |
Recall Event ID |
52130 |
Product Classification |
Venous Access Port Kits - Product Code OKE
|
Product |
Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121. |
Code Information |
Kit lots 802188 and 802198. Heparin flush lot 7113064. |
Recalling Firm/ Manufacturer |
Tri-State Hospital Supply Corporation 301 Catrell Drive Howell MI 48843
|
For Additional Information Contact |
517-546-5400 Ext. 1156
|
Manufacturer Reason for Recall |
The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
|
FDA Determined Cause 2 |
Material/Component Contamination |
Action |
Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it. |
Quantity in Commerce |
100 kits |
Distribution |
Indiana, Mississippi, Ohio and Tennessee. |
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.
|