Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code

FDA device recall Z-0933-2011 · posted 2011-01-21 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock.

Action taken

The firm, Baxter, telephoned the one customer on November 17, 2010, informing them that electrical safety testing was not performed on their FloGard pump serial number 11091330FA during the last service. Since the test was not conducted on the pump, the device may not function as designed and could lead to a hazard of electrical shock. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter advised the customer that a Baxter Field Service Engineer would be sent to their facility to perform electrical safety testing or alternatively, the customer may choose to send the pump to Baxter for testing. If you have any questions regarding this information, please contact Vice President, Quality, GIS at 847-270-5507.

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

1 pump

Distribution

Nationwide distribution: WA only

Date initiated

2010-11-17

Date posted

2011-01-21

Date terminated

2011-03-16

Location

Round Lake, IL

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