|
Class 2 Device Recall Terumo APS1 |
|
Date Initiated by Firm |
November 10, 2006 |
Date Posted |
December 27, 2006 |
Recall Status1 |
Terminated 3 on June 19, 2008 |
Recall Number |
Z-0306-2007 |
Recall Event ID |
36349 |
510(K)Number |
K022947
|
Product Classification |
cardiovascular perfusion system - Product Code DTQ
|
Product |
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763. |
Code Information |
All units. Serial numbers 0011 through 0499. |
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 |
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
|
FDA Determined Cause 2 |
Other |
Action |
A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B. |
Quantity in Commerce |
488 |
Distribution |
Worldwide, including USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand 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.
|
|
|
|