CLASS III Device recall · Reported 5 Sep 2012 · FDA Enforcement Report
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery recalled
Baxter Healthcare is recalling Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery. The recall was initiated on 4 Mar 2011 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2269-2012
- FDA event ID
- 62881
- Recalling firm
- Baxter Healthcare, Round Lake, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Mar 2011
- FDA classified
- 24 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 4 Mar 2011 | Recall initiated by company | |
| 24 Aug 2012 | Classified by FDA | +539 days |
| 5 Sep 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 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.
Where it was distributed
45,865 units
Questions about this recall
Is Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery recalled?
Yes. Baxter Healthcare recalled Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery on 4 Mar 2011. The recall is Class III and its status is Terminated. Recall number Z-2269-2012.
Why was it 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
Which lots are affected?
product codes 2M8171 and 2M8171R, all serial numbers
Where was it sold?
45,865 units
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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