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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description 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: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Recall Number Z-2268-2012
Classification Class III
Code Info product codes 2M8170 and 2M8170R, all serial numbers
Product Distributed Qty 26,485 units
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 of .51 inches for the negative terminal diameter.

Event Detail

Event Id 62881
Product Type Devices
Status Terminated
Recalling Firm Baxter Healthcare Corp.
City Round Lake
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-03-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 45,865 units
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