CLASS II Device recall · Reported 21 Nov 2012 · FDA Enforcement Report
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature recalled
Terumo Cardiovascular Systems is recalling HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, distributed nationwide in the US. The recall was initiated on 16 Oct 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0278-2013
- FDA event ID
- 63344
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2012
- FDA classified
- 13 Nov 2012
- Reported
- 21 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2012 | Recall initiated by company | |
| 13 Nov 2012 | Classified by FDA | +28 days |
| 21 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
Nationwide CaliforniaHawaiiKansasLouisianaMichiganMissouriOregonPennsylvaniaUtahWisconsin
Questions about this recall
Is HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained recalled?
Yes. Terumo Cardiovascular Systems recalled HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained on 16 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0278-2013.
Why was it 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
Which lots are affected?
Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
Where was it sold?
Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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