Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the dig

FDA device recall Z-0159-2015 · posted 2014-10-31 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corp

Reason for recall

Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.

Action taken

Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.

Root cause

Device Design

Status

Terminated

Product code

OEZ

Quantity affected

Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units

Distribution

Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

Date initiated

2011-03-01

Date posted

2014-10-31

Date terminated

2014-11-06

Location

Ashland, MA