FDA Device

Sarns MP4 Cardioplegia Sets; catalog number 15501.

Hazard

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

What You Should Do

Remedy

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.

Products

Sarns MP4 Cardioplegia Sets; catalog number 15501.
Brand
Terumo Cardiovascular Systems Corp
UPC
Lot 322125

Units Affected

300