Devices

Device Recall Terumo Cardiovacular

제조사

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA

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Device Recall Terumo Cardiovacular Systems Heat Exchanger Coil
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. AR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI
  • 제품 설명
    Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .
  • Manufacturer
    Terumo Cardiovascular Systems Corp