Terumo HX2 Temperature Management System provides recall
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of…
Why was Terumo HX2 Temperature Management System provides recalled?
Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
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?
HX2 Temperature Management System, 120V Catalog # 809810 serial numbers: 00016, 0001 1116 HX2 Temperature Management System, 100V Catalog # 812231 serial numbers: 0001, 1002, PT0003, PT0004 HX2 Temperature Management System, 240V Catalog # 812240 serial numbers: 0001, 0002 HX2 Temperature Management System, Trial Kit Catalog # 809810TK serial numbers: 1001 1042
- Product
- Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 103 units
- Distribution
- US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.
- Recall date
- February 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)