Date Initiated by Firm |
January 13, 2008 |
Date Posted |
December 10, 2008 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number |
Z-0311-2009 |
Recall Event ID |
46314 |
Product Classification |
Level Sensor Pads - Product Code DTQ
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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.
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Code Information |
Lot Number 78925. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact |
800-521-2818
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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