Devices

Device Recall Terumo

  • Modèle / numéro de série
    Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AZ, CA, KY, IL, LA, MD, WA , WI
  • Description du dispositif
    Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump || The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: || Convenience Kit Identifier Code/Kit Lot Numbers: || 65077 FA17 || 62266-01 EP13 || 62266-01 FA31 || 63819-01 FC07 || 64034 FA03 || 64033 FD07 || 70131 FA03 || 70131 FA10 || 63607 FA31 || 63607 FD07 || 64091 FC07 || 64338 EP13 || 64338 FC07 || 70964 EP20 || 70964 FD07 || 70014-02 EP13 || 70014-02 FA03 || 70014-02 FC07 || 70014-02 FC07T || 70014-02 FD07 || 70226-01 FD07 || 64987 FA24 || 64987 FD14 || 62933-01 FD14 || 62984-01 FA24 || 63004-01 FA03 || 63004-01 FA24 || 63361-01 EP27 || 63118 EP13 || 63118-01 FA24 || 63118-01 FC28 || 63118-01 FD14
  • Manufacturer
    Terumo Cardiovascular Systems Corp
  • 1 Event

Fabricant

Terumo Cardiovascular Systems Corp
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA

138 dispositifs médicaux avec un nom similaire

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Device Recall Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers
  • Modèle / numéro de série
    Schein product code 629-9041, Model CL*E12NLA, lot numbers 040408, 0404080511, 040511, 0405110610, 040610, 040909; Schein product code 629-5978, Model CL*E15NLA, lot numbers 040406, 0404060511, 040511; Schein product code 629-1824, Model CL*E18NLA, lot numbers 031020, 0310201215, 031215; Schein product code 629-7278, Model CL*E20NLA, lot numbers 020604, 0206040711, 020711;
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Description du dispositif
    Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area
  • Manufacturer
    Asahi Medical Co Ltd
Device Recall Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers
  • Modèle / numéro de série
    Schein product code 629-3169, Model CL*EE12NLA, lot number 040116; Schein product code 629-8232, Model CL*EE15NLA, lot number 031212; Schein product code 629-5106, Model CL*E20NLA, lot numbers 031128, 0311281223, 031223;
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Description du dispositif
    Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*EE12NLA - 1.2 m2 surface area, CL*EE15NLA - 1.5 m2 surface area and CL*EE20NLA - 2.0 m2 surface area
  • Manufacturer
    Asahi Medical Co Ltd
Device Recall Terumo Analyzer, Ion, HydrogenIon (pH), BloodPhase, Indwelling
  • Modèle / numéro de série
    Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP,  6O8AP6O8AD
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait
  • Description du dispositif
    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
  • Manufacturer
    Terumo Cardiovascular Systems Corp
Device Recall Terumo APS1
  • Modèle / numéro de série
    All units. Serial numbers 0011 through 0499.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • Description du dispositif
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
  • Manufacturer
    Terumo Cardiovascular Systems Corp
Device Recall Terumo APS1
  • Modèle / numéro de série
    All units Serial numbers 0006 through 0213.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • Description du dispositif
    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).
  • Manufacturer
    Terumo Cardiovascular Systems Corp
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