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U.S. Department of Health and Human Services

Class 2 Device Recall Pressure Monitoring Kit

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 Class 2 Recall
Pressure Monitoring Kit
see related information
Date Posted June 22, 2011
Recall Status1 Terminated on July 18, 2012
Recall Number Z-2620-2011
Recall Event ID 58838
Premarket Notification
510(K) Numbers
K022947  K871131  K915183 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
Code Information LG22, LK17, LK31, LN16
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's manufacturing process.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 3, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were sent 10 replacement pressure monitoring kits with the removal notice as immediate replacements. The firm will send additional replacements to customers that have more than 10 units of affected product as noted on the Customers' returned reponse form. Customers that received the custom packs were provided stickers to identify the recalled packs. The customers were instructed not to open the packs to remove the affected pressure monitoring kit prior to clinical use, but to replace the pressure domes at the time of use. For more information please contact Terumo Cardiovascular Customer Service at 800- 521-2818.
Quantity in Commerce 1515 all custom packs
Distribution Worldwide Distribution -- USA (nationwide )including the states AR, CA, FL, GA, MO, MT, NC, ND, OK, OR, PA, TN, TX, UT, VA, WA and WY, and the countries of Argentina, Belgium, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatamala, Honduras, Hong Kong, Indonesia, Kuwait, Malaysia, Mexico, Pakistan, Panama, Philippines, Singapore, South Korea, Thailand, United Arab Emirates, Uruguay 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
510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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