Sarns MP4 Cardioplegia Sets; catalog number 15501.

FDA device recall Z-0664-03 · posted 2003-03-20 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corp

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DTR

Quantity affected

300

Distribution

United States

Date initiated

2003-02-25

Date posted

2003-03-20

Date terminated

2003-06-06

Location

Ann Arbor, MI