Class III — Baxter Healthcare Corp.
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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 |
| Product | 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. |
| Quantity | 26,485 units |
| Distribution | 45,865 units |
| Initiated | 2011-03-04 |
| Classified | 2012-08-24 |
| Terminated | 2012-08-27 |
| Recall number | Z-2268-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Baxter Healthcare Corp. (Z-2268-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62881/
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