Enforcement Report - Week of November 21, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0278-2013 |
| Classification | Class II |
| Code Info | Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116. |
| Product Distributed Qty | 19 units |
| 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, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. |
Event Detail
| Event Id | 63344 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Terumo Cardiovascular Systems Corporation |
| City | Ann Arbor |
| State | MI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-16 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI |
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