Z-0004-05

AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis

Name: Z-0004-05 AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis
Creator: Ameriwater Inc
Published: 2004-09-03
License: https://open.fda.gov/license/

AmeriWater LLC. / initiated 2004-09-03 / Terminated

FDA source

Ameriwater Inc began a recall of AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis on 2004-09-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0004-05
Status: Terminated
Initiated: 2004-09-03
Posted: 2004-10-05
Terminated: 2007-01-26
Recalling firm: AmeriWater LLC.
Product: AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
Product code: FIP Subsystem, Water Purification
Reason for recall: 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.
FDA root cause: Other
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.
Quantity in commerce: 148 units.
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 codes and lots: 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 code FIP

K922695UnclassifiedKinetic Technology Precision Adjustor Mod. Shlcp-5Kinetic Technology, Inc. / cleared 1992-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)