The Recall Desk

FDA (Devices) recall action 72010

Terumo Cardiovascular Systems Corp recalled 7 products on 2015-09-30

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2015-09-30
Critical
0
Units
124

Why these products were recalled

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrator Component

    Terumo is recalling 15 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 High Performance Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2015-09-30

    Terumo Cardiovascular Procedure Kits Recalled Due to Defective Hemoconcentrators

    Terumo is recalling 19 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application…
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling 5 Custom Cardiovascular Procedure Kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by…
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 17 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 30 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Distribution
    4 states