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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Sarns Level Sensor II Pads

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 Class 2 Recall
Terumo Sarns Level Sensor II Pads
see related information
Date Posted December 10, 2008
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0311-2009
Recall Event ID 46314
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir.
Code Information Lot Number 78925.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were notified via recall letter (Urgent Medical Device Removal letter) dated 2/13/08 and requested to report stocks on hand so that replacements could be sent.
Quantity in Commerce 31,980 pads (25,620 to U.S. and 6,360 international)
Distribution Worldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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