Recalls / —

—#48461

Product

Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

FDA product code

DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

All units Serial numbers 0006 through 0213.

Why it was recalled

Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2006-11-10

Posted by FDA

2006-12-27

Terminated

2008-06-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.