Events

Recall of AmeriWater Portable RO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ameriwater Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29925
  • Event Risk Class
    Class 2
  • Event Number
    Z-0004-05
  • Event Initiated Date
    2004-09-03
  • Event Date Posted
    2004-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34793
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Subsystem, Water Purification - Product Code FIP
  • Reason
    The device has a potential risk of failure caused by faulty wiring within the electrical component. the wires can overheat and eventually break in two.
  • Action
    The firm notified consignee''s via letter sent on September 3, 2004. Consignees were provided in the letter with written instructions to correct the problem and were instructed to fax a return response form identifying that the corrections had been completed.

Device

AmeriWater Portable RO
  • Model / Serial
    Serial Numbers effected: 21013, 21014, 21026, 21031, 21042, 21052, 21053, 21071, 21072, 21073, 21079, 21080, 21090, 21091, 21092, 21100, 21101, 21110, 21111, 21121, 21122, 21125, 21127, 21193, 21194, 21200, 21201, 21203, 21204, 21205, 21208, 21210, 21215, 21222, 21223, 21236, 21237, 21240, 21258, 21259, 21263, 21270, 21328, 21333, 21336, 21338, 21352, 21371, 21379, 21384, 21387, 21388, 21015, 21016, 21017, 21021, 21023, 21024, 21032, 21033, 21034, 21035, 21036, 21043, 21049, 21050, 21051, 21054, 21066, 21089, 21093, 21094, 21095, 21097, 21098, 21108, 21109, 21123, 21126, 21128, 21142, 21143, 21156, 21157, 21160, 21162, 21163, 21164, 21165, 21166, 21167, 21168, 21169, 21176, 21178, 21179, 21180, 21183, 21185, 21186, 21191, 21192, 21212, 21216, 21217, 21224, 21225, 21228, 21229, 21244, 21249, 21260, 21268, 21269, 21271, 21272, 21274, 21275, 21276, 21282, 21283, 21298, 21299, 21300, 21302, 21307, 21311, 21316, 21329, 21332, 21339, 21342, 21343, and 21346.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed in the following states: MI, HI, PA, IL, CA, CO, OH, TX, NY, SD, ON, IN, NC, MN, KY, SC, TN, FL, NJ, GA, MD, DE, AR, and MA.
  • Product Description
    AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
  • Manufacturer
    Ameriwater Inc

Manufacturer

Ameriwater Inc
  • Manufacturer Address
    Ameriwater Inc, 1257 Stanley Ave, Dayton OH 45404-1013
  • Source
    USFDA