Recall Z-1116-2015
Terumo Cardiovascular Systems Corporation · initiated February 6, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
Codes / lots: 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
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
On 2/6/2015, URGENT MEDICAL DEVICE RECALL notifications were mailed to the affected hospitals. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call customer service at 1-800-521-2818.
Details
- Recall number
- Z-1116-2015
- Initiated
- February 6, 2015
- Posted by FDA
- February 13, 2015
- Terminated
- October 17, 2016
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- 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.
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI