Product Wiki · Recalls · U.S. FDA — Device Enforcement

Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery… — recall Z-2269-2012

U.S. FDA — Device Enforcement · United States · 2011-03-04 · Class III

As described by U.S. FDA — Device Enforcement: 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 sm

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2269-2012
Date of alert
2011-03-04
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Baxter Healthcare Corp.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
45,865 units
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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