—#102829

Product

Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.

FDA product code: KRI — Accessory Equipment, Cardiopulmonary Bypass
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: Product code: 195240 Batch Numbers 616814, 618558, 619369, and 619396. Lot codes: 123360, 129471, 29371-1, 29371-2, 36281, 40406, 42244, 44233, 49385, 51662, 56778, 58289, 61740, 64408, 68194, 70674, 75069, 78925, 80039, 82191, 86889, 90106, 90332, 91899, 98907, 99493, 99495, 101524, 105072, and 105808.

Why it was recalled

Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Terumo Cardiovascular Systems Corp. sent an "Urgent Medical Device Removal" notice dated August 10, 2011 to all affected customers. The notice instructs customers to discard all remaining level sensor pads that do not have an expiration date on the package, and notify Terumo of the number of affected pads via a response form. Terumo will replace recalled product. For questions on this recall call Terumo Customer Service at (800) 521-2818, 8 am-6 pm EST.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.

Timeline

Recall initiated: 2011-08-12
Posted by FDA: 2011-09-09
Terminated: 2012-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102829. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.