Enforcement Report - Week of August 1, 2012
-
Back to Previous Page
Event Detail
| Event ID | 62007 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | CareFusion 303, Inc. |
| City | San Diego |
| State | CA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-25 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. | not available | Class I | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen. | 112,912 units total (106,888 units in US) | Z-2076-2012 |
-
