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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Sarns Level Detect II Mount Pads

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  Class 2 Device Recall Terumo Sarns Level Detect II Mount Pads see related information
Date Initiated by Firm August 12, 2011
Date Posted September 09, 2011
Recall Status1 Terminated 3 on June 20, 2012
Recall Number Z-3176-2011
Recall Event ID 59455
Product Classification Cardiovascular Sensor Pads - Product Code KRI
Product Terumo Sarns Level Sensor II Pads.
Terumo Cardiovascular Systems Corporation.

Used to attach level sensors to the sides of the venous reservoir.
Code Information 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.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Terumo Customer Service
800-521-2818
Manufacturer Reason
for Recall		 Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action 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.
Quantity in Commerce 1,531,440 devices
Distribution Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.
Total Product Life Cycle TPLC Device Report
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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