Recalls / —

—#26348

Product

Sarns MP4 Cardioplegia Sets; catalog number 15501.

FDA product code

DTR — Heat-Exchanger, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

Lot 322125

Why it was recalled

There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.

Root cause (FDA determination)

Other

Action the firm took

Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd., Ann Arbor, Michigan 48103

Distribution

Distribution pattern

United States

Timeline

Recall initiated

2003-02-25

Posted by FDA

2003-03-20

Terminated

2003-06-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26348. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.