Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Sarns Level Sensor II Pads

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Terumo Sarns Level Sensor II Padssee related information
Date Initiated by FirmJanuary 13, 2008
Date PostedDecember 10, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall NumberZ-0311-2009
Recall Event ID 46314
Product Classification Level Sensor Pads - Product Code DTQ
ProductTerumo 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.
FEI Number 1828100
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
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		Nonconforming Material/Component
ActionConsignees 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 Commerce31,980 pads (25,620 to U.S. and 6,360 international)
DistributionWorldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.
Total Product Life CycleTPLC 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.
-
-