Enforcement Report - Week of September 5, 2012
-
Back to Previous Page
Product Detail
| Product Description | Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication. |
|---|---|
| Recall Number | Z-2268-2012 |
| Classification | Class III |
| Code Info | product codes 2M8170 and 2M8170R, all serial numbers |
| Product Distributed Qty | 26,485 units |
| Reason For Recall | Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ±.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter. |
Event Detail
| Event Id | 62881 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Baxter Healthcare Corp. |
| City | Round Lake |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-03-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 45,865 units |
-
