Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These

FDA device recall Z-2268-2012 · posted 2012-08-24 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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

Action taken

Baxter sent a Safety Alert letter on January 11, 2011 for the InfusO.R. Pump. Baxter expanded the scope of the recall to include the Mini-Infusers System and sent an Urgent Device Correction letter dated March 4, 2011, via First Class mail to all affected customers. The letters informed the customers that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The customers were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future reference. For Technical questions call Baxter Global Technical Services at 1-800-843-7867. For question regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Quantity affected

26,485 units

Distribution

45,865 units

Date initiated

2011-03-04

Date posted

2012-08-24

Date terminated

2012-08-27

Location

Round Lake, IL

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