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U.S. Department of Health and Human Services

Class 2 Device Recall CDI 500 Blood Parameter Monitoring System

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  Class 2 Device Recall CDI 500 Blood Parameter Monitoring System see related information
Date Initiated by Firm August 07, 2015
Date Posted September 09, 2015
Recall Status1 Terminated 3 on May 31, 2016
Recall Number Z-2742-2015
Recall Event ID 71937
510(K)Number K133658  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product CDI 500 Blood Parameter Monitoring System.
Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
Code Information 500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500; software version 1.69.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact Mary Swift
734-741-6173
Manufacturer Reason
for Recall		 Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
FDA Determined
Cause 2		 Software design
Action A voluntary Urgent Medical Device Correction notice that clearly explains initial in-vivo calibration requirements, device operating ranges, and temperature measurements was sent on 08/17/2015, via express mail to consignees of CDI System 500 v1.69. Following the initial notice, Terumo will be updating the Operators Manual and will send the new manual to each consignee when available. One manual per unit at each facility will be provided. Customers with questions and return response forms may contact: Terumo Recall Email: tcvs.recall@terumomedical.com Terumo Recall Fax: 734-741-6149 Terumo CVS Customer Service: 1.800.521.2818, Monday - Friday, 8 a.m.  6 p.m. ET.
Quantity in Commerce 4638
Distribution Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, Canada, Chile, Colombia, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates.
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 = DRY and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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