Sarns MP4 Cardioplegia Sets; catalog number 15501.
FDA Recall Z-0664-03 · Posted 2003-03-20
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTR
Date Initiated2003-02-25
Date Terminated2003-06-06
Product Quantity300
Reason for Recall
There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
Firm Action
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
Distribution Pattern
United States
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.