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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 Device Recall Pressure Monitoring Kit see related information
Date Initiated by Firm May 03, 2011
Date Posted June 22, 2011
Recall Status1 Terminated 3 on July 18, 2012
Recall Number Z-2613-2011
Recall Event ID 58838
510(K)Number k915183  K022947  K871131  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
Code Information 0511829, 0519808, 0522673, 0537066, 0538520, 0544571, 0548624, 0552118, 0555878, 0557544, 0563808, 0565139, 0571582, 0575070, 0578021, 0578529, 0579318, 0580173, 0582267, 0584399, 0587165, 0589587, 0592742, 0593799, 0595311, 0595312, 0604098.
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
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
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 19495 units
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 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.
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.