HX2 Temp Manage SYS 120V The Terumo HX2 Temperature recall
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled…
Why was HX2 Temp Manage SYS 120V The Terumo HX2 Temperature 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
- Product
- HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 19 units
- Distribution
- Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
- Recall date
- November 21, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)