FDAFDA · Food and drugs·Recall number Z-0278-2013
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.
Published November 21, 2012 · Recall initiated: October 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
- Lot
- Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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