The Recall Desk

FDA (Devices) recall action 63344

Terumo Cardiovascular Systems Corporation recalled 2 products on 2012-11-21

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-11-21
Critical
0
Units
34

Why these products were recalled

Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up

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

1–2 of 2

  • HighFDA (Devices)··2012-11-21

    Terumo HX2 Temperature Management System Recalled for Board Defect

    Terumo is recalling 15 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.

    Product
    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
    Category
    Distribution
    10 states
  • HighFDA (Devices)··2012-11-21

    Terumo HX2 Temperature Management System Recalled for Board Defects

    Terumo is recalling 19 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.

    Product
    HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
    Category
    Distribution
    10 states