Z-2269-2012 Class III Terminated
FDA device recall Z-2269-2012 was initiated by Baxter Healthcare Corp. on Mar 4, 2011 and is designated Class III. 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… The recall status is terminated (terminated Aug 27, 2012). Affected quantity: 19,380 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2012
- Initiation Date
- Mar 4, 2011
- Termination Date
- Aug 27, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,380 units
Product Description
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.
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
Distribution Pattern
45,865 units
Code Information
product codes 2M8171 and 2M8171R, all serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2269-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026