The Recall Desk

FDA (Devices) recall action 74389

Terumo Cardiovascular Systems Corporation recalled 4 products on 2016-07-27

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-07-27
Critical
0
Units
25,648

Why these products were recalled

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

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

1–4 of 4

  • ModerateFDA (Devices)··2016-07-27

    Terumo HX2 Temperature Management Systems Recalled Due to Sanitizer Availability

    Terumo CVS is voluntarily recalling HX2 Temperature Management Systems because the Interchlor sanitizer required for cleaning is no longer available.

    Product
    HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-27

    Terumo Recalls Sarns TCM II Heater-Cooler Units Due to Sanitizer Discontinuation

    Terumo CVS is voluntarily recalling Sarns TCM II heater-cooler units because the Interchlor sanitizer referenced in cleaning instructions is no longer available.

    Product
    Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-27

    Terumo Sarns Dual Cooler-Heater Recalled Due to Missing Sanitizer

    Terumo CVS is voluntarily recalling Sarns Dual Cooler-Heater devices because the distributor no longer sells the Inter chlor sanitizer required for cleaning.

    Product
    Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero…
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2016-07-27

    Terumo Recalls Sarns Temperature Control Units Due to Sanitizer Discontinuation

    Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.

    Product
    Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for…
    Category
    Distribution
    51 states