Date Initiated by Firm |
October 06, 2005 |
Date Posted |
January 09, 2007 |
Recall Status1 |
Terminated 3 on February 01, 2007 |
Recall Number |
Z-0292-2007 |
Recall Event ID |
36392 |
510(K)Number |
K022947
|
Product Classification |
Perfusion System - Product Code DTQ
|
Product |
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. |
Code Information |
Serial numbers 0976 and 0979. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
|
For Additional Information Contact |
800-521-2818
|
Manufacturer Reason for Recall |
Six inch roller pumps were mislabeled as 4 inch roller pumps.
|
FDA Determined Cause 2 |
Other |
Action |
The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06. |
Quantity in Commerce |
2 |
Distribution |
Worldwide-Michigan and Singapore. |
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 = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
|