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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Cardiovacular Systems Heat Exchanger Coil

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 Class 2 Device Recall Terumo Cardiovacular Systems Heat Exchanger Coilsee related information
Date Initiated by FirmNovember 07, 2002
Date PostedApril 03, 2003
Recall Status1 Terminated 3 on August 06, 2015
Recall NumberZ-0298-03
Recall Event ID 25078
510(K)NumberK000977 
Product Classification Heat-Exchanger, Cardiopulmonary Bypass - Product Code DTR
ProductHeat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .
Code Information TCVS Product code number 0006-00011; all coils in custom cardiovascular procedure kits within their labeled shelf life of 24 months (i.e. kits made 12/1/2000 to 10/25/2002) as follows: Procedure Kit Codes Produced in Lot Lot # 63182-02 CA02 70035; 8539TX CA07 62973; 63153;63688-01; 8539TX CA14 63688-01 CA14T 62973 CA28 8539TX CC04 63688-01; 8525T CC11 63688-01 CC11T 63688-01 CC11TR 62786; 62973;63432; 70060; 63688-01 CC18 63688-01 CC18T 63323-02; 63153 CC25 62336-01; 7957-02; 8525T CD04 63323-02 CD11 70035 ;8539TX; CD18 63182-02; 8525T CD25 62417-03; 62973-01; 63182-02; 63688-01 CE01 63688-01 CE01R 62973-01; 63688-01 CE01T 70187; 62786 CE08 70017; 62973-01 ;63182-02; 63688-01 CE15 63182-02; 63688-01 CE15T 63688-01 CE15TR 70001; 63182-02 CE22 63323-02 CE29 63432; 62336-01; 63079-01; 8525T; 63070-01;  63182-02 CF06 131246-01; 63014-01; 63688-01 CF13 63688-01 CF13R 63688-01 CF13T 70001; 63182-02 CF20 63323-02 CF28 63064 ;62336-01; 62544-01 CG03 63153; 70035; 62973-01 CG10 63064; 62417-03; 62973-01; 63688-01 CG17 63064 CG17R 63079-01; 63688-01 CG24 62336-01 CH01 62786; 63432;62973-01; 63688-01 CH08 62973-01 CH08T 70035; 63323-03; 63688-01 CH15 70001; 63688-01; 63182-02 CH22 63688-01 CH22T 63064; 70001; 70251; 131246-01; 63014-01 CH29 64130; 62544-01; 62973-01 CK05 64130 CK12 64130 CK12T 64130; 63079-01 CK19 63014-01; 63323-03 CK26 70085 CL03 62973-01; 8539TXC CL09 64203; 62973-01; 63064-01 CL16 70413; 8525T CL23 63298 YP04 62417-03 YP11 62336-01 YP18 63014; 8539TX ZA08 62973 ;8539TX ZA22 62973; 63079 ZA29 63432 ZC05 62973; 63014; 63432; 62513-01 ZC12 63014; 63079; 63298; 62973 ZC19 63153 ;63315; 63432; 62361-02; 62513-01 ZC26 62513-01 ZC26T 62786; 63315; 63323 ZD05 63064; 63323; 62544-01; 8525T; 62513-01 ZD12 62361-02; 62544-01; 63323 ZD19 63014 ;8539T; 62786 ZD26 62786; 63315 ZE02 63014; 63064; 63432; 8525T ZE09 63153; 62544-01; 63323 ZE16 62973 ;63323 ZE23 63014 ZE30 63064; 62417-03 ZF07 63064 ZF07R 62786; 63153 ZF14 62544-01; 8539TX ZF21 8539TX ZF21T 8539TX ZF21TR 62973; 63014; 63298 ZF29 62973; 63432; 63315-01 ZG04 62973; 8539TX ZG11 63323; 63079-01 ZG18 63323 ZG18T 62973; 63070; 63432; 62417-03; 63315-01 ZG25 63688; 70001; 63315-01; 8335TX ZH09 62973; 63688; 63079-01; 63153 ZH16 63688; 70001; 62336-01; 8525T ZH23 63688; 70001 ZH23T 63688; 63726; 8539TX ZH30 63688 ZH30R 63688 ZK06 63688 ZK06T 70012 ZK20 63014 ZK20R 70012 ZK20T 62786; 63079-01; 8525T; 8539TX ZK27 8539TX ZK27R 62786; 62973; 63014; 62417-03; 63323-01 ZL04 63014 ZL04R 62973 ZL04T 63014 ZL10 63014 ZL10T 8539TX; 8525T ZL17 62544-01; 63323-01; 8525T ZL24 63323-01 ZL24T 70073 ZM08 62786 ZM15 62786; 62417-03; 8525T ZM22 63014; 63688; 70085; 62336-01; ZM29 70085 ZM29R 62973; 63153; 63432; 63688 ZN05 62973 ZN05T 62973 ZN05TR 8539TX ZN12 8525T ZN19 62417-03; 62544-01 ZN26 62336-01 ;8525T; 63182-02 ZP03 8525T; 63182-02 ZP03T 63064; 63751;63815 ZP10 70106; 63182-02 ZP17   
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information ContactTerri Brinsfield
800-262-3304
Manufacturer Reason
for Recall		Heat exchanger may contain loose particulate matter
FDA Determined
Cause 2		Other
ActionTerumo Cardiovascular Systems notified customers by telephone on 11/8/02 by telephone, fax, and mail to advise distributors and end-users to cease use of the Heat Coil.. A follow-up letter issued to the accounts with instructions for the return of product.
Quantity in Commerce10035
DistributionNationwide. AR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI
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.
510(K) Database510(K)s with Product Code = DTR
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