|
Class 3 Device Recall Terumo APS 1 |
|
Date Initiated by Firm |
April 01, 2004 |
Date Posted |
June 30, 2007 |
Recall Status1 |
Terminated 3 on June 11, 2008 |
Recall Number |
Z-0923-2007 |
Recall Event ID |
37244 |
510(K)Number |
K022947
|
Product Classification |
Perfusion System - Product Code DTQ
|
Product |
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. |
Code Information |
Serial numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected. |
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 |
A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.
|
FDA Determined Cause 2 |
Other |
Action |
The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur. |
Quantity in Commerce |
525 total for both models |
Distribution |
Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates. |
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.
|
|
|
|