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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a functional failure (device not operating) rather than a direct injury risk.
Plain-English summary
Baxter Healthcare Corp. is recalling the Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery-operated syringe infusion pump. The recall includes 26,485 units, with a total distribution of 45,865 units. The affected product codes are 2M8170 and 2M8170R, covering all serial numbers, and the recall includes refurbished units.
The recall is due to a defect in the battery spring contact. If a battery with the minimum contact diameter of .51 inches is placed on the battery spring, which has an inner diameter of .53 inches, the electrical circuit will not be completed. As a result, the Mini-Infuser will not operate. The source text notes that IEC 60086-2 and ANSI 08 standards specify a minimum contact diameter, implying the device's spring design may not accommodate batteries at the lower end of standard specifications.
This device is intended for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Users of these infusion pumps should contact Baxter Healthcare Corp. for further instructions on how to proceed with the recall.
The recalled product
- 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:
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 26,485
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- product codes 2M8170 and 2M8170R
- all serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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