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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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, aligning with the 'Low' severity criteria for documentation or minor defects.
Plain-English summary
Baxter Healthcare Corp. is recalling 19,380 units of the Mini-Infuser Model 300XL Multispeed Infusion Pump. The affected products include product codes 2M8171 and 2M8171R, covering all serial numbers and including refurbished units. These devices are prescription battery-operated syringe infusion pumps intended for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician.
The recall is due to a defect in the Mini-Infuser Battery Spring, which has a flat contact measuring .53 inches ±.01 inches on the inner diameter of the spring coil. If a battery with the minimum contact diameter of .51 inches is placed on this spring, an electrical circuit will not be completed, and the Mini-Infuser will not operate. This failure mode is related to specifications in IEC 60086-2 and ANSI 08 standards.
The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. No specific instructions for consumers are provided in the source text, but the device is intended for medical use under physician prescription.
The recalled product
- 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…
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 19,380
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 2M8171 and 2M8171R
- 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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