—#126930

Product

Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K922992
Affected lot / code info: Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 20 I 0

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

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

Timeline

Recall initiated: 2011-03-01
Posted by FDA: 2014-10-31
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.