Device Recall Terumo

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, KY, IL, LA, MD, WA , WI
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA

138 devices with a similar name

Learn more about the data here

  • Model / Serial
    Hand crank serial numbers 1197 through 1214.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
  • Manufacturer
  • Model / Serial
    Serial numbers 0011 through 0039, 0041 through 0308, 0310 through 0313, 0315, 0316, 0319 through 0321 and 0324 may be affected by this issue. Serial numbers 0238 and 0282 have been corrected to date.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.
  • Product Description
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
  • Manufacturer
  • Model / Serial
    Serial numbers 0006 through 0066, 0100 through 0144, 0146, 0147 and 0149 may be affected by this issue. Serial number 0046 have been corrected to date.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.
  • Product Description
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
  • Manufacturer
  • Model / Serial
    Hand crank serial numbers 1621 and 1622.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
  • Manufacturer
  • Model / Serial
    Hand crank serial numbers 1240 through 1247.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
  • Manufacturer
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