• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Perfusion System

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


New Search Back to Search Results
 Class 2 Recall
Terumo Perfusion System
see related information
Date Posted November 07, 2008
Recall Status1 Terminated on August 04, 2009
Recall Number Z-0295-2009
Recall Event ID 49604
Premarket Notification
510(K) Number
K871131 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195215. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 base. Level sensors are attached to the color coded connectors on the module and then to a hard-shell reservoir. Level detection is used to monitor blood levels in hard-shell reservoirs.
Code Information Serial Numbers: 2036, 3015 through 3086, 3090, 3092 through 3137, 1191x, 2012x through 2035x, 2037x through 2274x, 2276x through 2284x, 2287x through 2290x, 2292x, 2294x through 2297x, 2299x through 2302x, 2304x, 2306x through 2308x, 2311x through 2313x, 2315x through 2326x, 2328x, 2330x through 2337x, 2340x through 2341x, 2343x, 2346x, 2349x through 2352x, 2354x through 2356x, 2358x, 2360x, 2363x through 2365x, 2367x through 2375x, 2379x, 2381x through 2384x, 2391x, 2392x, 2394x, 2395x, 2398, 2399x, 2403x, 2404x, 2405x, 2407x, 2408x, 2410x, 2411x, 2413x, 2415x, 2416x, 2417x, 2419x, 2420x, 2421x, 2423x through 2427x, 2432x, 2435x through 2441x, 2443x through 2466x, 2468x through 2471x, 2473x through 2491x, 2497x through 2500x, 2502x, 2518x, 2521x, 2527x, 2529x through 2533x, 2548x and 2549x.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor, Michigan 48103
Manufacturer Reason
for Recall
The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008. For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 574
Distribution Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.
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.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = 3M HEALTH CARE, SARNS
-
-