The Recall Desk

FDA (Devices) recall action 62881

Baxter Healthcare Corp. recalled 2 products on 2012-09-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-09-05
Critical
0
Units
45,865

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Devices)··2012-09-05

    Baxter Mini-Infuser Model 300XL Infusion Pump Recalled for Battery Contact Defect

    Baxter Healthcare is recalling 19,380 Mini-Infuser Model 300XL infusion pumps because a battery contact defect may prevent the device from operating.

    Product
    Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the…
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2012-09-05

    Baxter Mini-Infuser 150XL Infusion Pump Recalled for Battery Contact Defect

    Baxter Healthcare is recalling Mini-Infuser Model 150XL infusion pumps because a battery contact defect may prevent the device from operating.

    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.…
    Category
    Distribution
    0 states