AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com.

FDA device recall Z-2321-2012 · posted 2012-09-06 · Terminated

Recall details

Recalling firm

AmeriWater Inc

Reason for recall

The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.

Action taken

The firm, AmeriWater, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2012, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; remove affected devices from service until the correction is completed to prevent malfunction of the device during patient treatment; and complete and return the attached response form to AmeriWater within 30 days via fax to 937/461-1988 Attn: Quality Assurance. AmeriWater dealer will be contacting their customers to schedule replacement of the fuses. If you have any questions, contact your local AmeriWater dealer or AmeriWater customer service at 1-800-535-5585.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FIP

Quantity affected

80 Units

Distribution

Worldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.

Date initiated

2012-08-09

Date posted

2012-09-06

Date terminated

2014-04-17

Location

Dayton, OH

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