Date Initiated by Firm |
March 28, 2014 |
Date Posted |
April 16, 2014 |
Recall Status1 |
Terminated 3 on December 12, 2014 |
Recall Number |
Z-1465-2014 |
Recall Event ID |
67925 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
Product |
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 |
Code Information |
Lot Number: RA-27 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 28 Howe St Ashland MA 01721-1305
|
For Additional Information Contact |
SAME 800-262-3304
|
Manufacturer Reason for Recall |
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Terumo CVS contacted the affected user on 3/28/14 by phone via phone script to discontinue use and return all affected units in inventory. Terumo CVS will replace or issue credit for returned product. |
Quantity in Commerce |
37 units |
Distribution |
CA |
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.
|