Recall Z-0278-2013
Terumo Cardiovascular Systems Corporation · initiated October 16, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
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
FDA-determined cause: Nonconforming Material/Component
Action taken
TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards. Customers with questions were instructed to call 1-800-621-2818. For questions regarding this recall call 734-741-6173.
Details
- Recall number
- Z-0278-2013
- Initiated
- October 16, 2012
- Posted by FDA
- November 13, 2012
- Terminated
- July 11, 2013
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 19 units
- Distribution
- Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0279-2013 Class II | Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a…Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2… | 10/16/2012Terminated |