—#85896

Product

Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.

FDA product code: KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K020998
Affected lot / code info: Product Number 164275X, Serial Numbers: KP01, KP15, LA05, LA12, LA19, LC02, LC09, LC23, LD02, LD09, LD16, LD30, LE06, LE08, LE13, LE20, LE27, LE29, LF04 and LF07.

Why it was recalled

The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

Root cause (FDA determination)

Device Design

Action the firm took

Terumo Cardiovascular Systems Corporation notified consignees of an "Urgent Medical Device Correction" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form. For further information, contact Terumo CVS Customer Service at 1-800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-07-06
Posted by FDA: 2009-12-17
Terminated: 2011-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.