FDA Device Recall Z-0004-05: Ameriwater Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-05.

Recall Res Number

Z-0004-05

Recalling Firm / Manufacturer

Ameriwater Inc

FEI Number

1000515504

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-03

Date Posted

2004-10-05

Date Terminated

2007-01-26

Product Code

FIP

Event Number

29925

Product Quantity

148 units.

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

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.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers 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.

Related Establishments / Registrations

BETTER WATER, INC. Registration: 1055109 View Registration
Fresenius Medical Care Renal Therapies Group, LLC Registration: 1225714 View Registration
AMERIWATER LLC. Registration: 1530185 View Registration
NELSON ENVIRONMENTAL TECHNOLOGIES, INC. Registration: 1651434 View Registration
BTI Filtration Registration: 1651723 View Registration
MESA LABORATORIES, INC. Registration: 1720309 View Registration
SERIM RESEARCH CORP. Registration: 1833387 View Registration
HACH COMPANY Registration: 1833407 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
CULLIGAN SOFT WATER SERVICE CO. Registration: 2135346 View Registration
IONISOS Registration: 3002807295 View Registration
B. Braun Avitum AG Registration: 3002879653 View Registration
NEPHROS, INC. Registration: 3003337893 View Registration
Veolia Water Treatment & Solutions Registration: 3003550196 View Registration
ISOPURE, CORP. Registration: 3003768032 View Registration
Evoqua Water Technologies LLC Registration: 3004057358 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
B & G MFG. CO. Registration: 3004188066 View Registration
Fresenius USA Manufacturing, Inc. Registration: 3005162618 View Registration
Haemotec, a division of Fresenius Medical Care Canada Inc. Registration: 3005578748 View Registration
SARMED SRL Registration: 3005695808 View Registration
Evoqua Water Technologies - South Windsor Registration: 3006029151 View Registration
STAUBACH BARROR WATER SYSTEMS INC. Registration: 3006426779 View Registration
Bieffe Medital Manufacturing Oued Ellil Tunisia Registration: 3006755813 View Registration
B. BRAUN AVITUM AG Registration: 3007007791 View Registration
Ferry Machine Corporation Registration: 3009959868 View Registration
FIRST ARTICLE INC Registration: 3010032903 View Registration
J&B PRECISION, INC. Registration: 3010041430 View Registration
FLEX-CELL PRECISION, INC. Registration: 3010120135 View Registration
J & J Precision Technologies, LLC Registration: 3010120148 View Registration
IONISOS Registration: 3010178296 View Registration
Outset Medical, Inc. Registration: 3010355846 View Registration
VIVONIC GMBH Registration: 3010850471 View Registration
AXIAL MEDICAL Registration: 3010863450 View Registration
NELSON ENVIRONMENTAL TECHNOLOGIES, INC. Registration: 3010866895 View Registration
NELSON ENVIRONMENTAL TECHNOLOGIES, INC. Registration: 3010867648 View Registration
SPECIALTY WATER TECHNOLOGIES, INC. Registration: 3012119281 View Registration
Evoqua Water Technologies - Jacksonville Registration: 3013507157 View Registration
B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
TOTAL QUALITY MEDICAL, INC. Registration: 3014144799 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
Steril Verona srl Registration: 3015136750 View Registration
ERIKA DE REYNOSA, S.A. DE C.V. Registration: 3015335038 View Registration
DIALITY, INC. Registration: 3015349756 View Registration
TST GmbH Registration: 3016096143 View Registration
Baja Fur S.A. de C.V. Registration: 3017552925 View Registration
Evoqua Water Technologies - Milpitas Registration: 3017974963 View Registration
Evoqua Water Technologies LLC Registration: 3019131 View Registration
VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED Registration: 3032828299 View Registration
Pabst Transport GmbH & Co. KG Registration: 3035708507 View Registration
Baja Fur S.A. de C.V. Registration: 3038138522 View Registration
Vantive US Healthcare LLC Registration: 3038195011 View Registration
GXO Logistics H France Registration: 3043014136 View Registration
FERRY MACHINE CORPORATION Registration: 3043543260 View Registration
GAMBRO INDUSTRIES Registration: 8010182 View Registration
ERIKA DE REYNOSA, S.A. DE C.V. Registration: 8030665 View Registration
GAMBRO DASCO S.P.A., BLOOD LINE DIVISION Registration: 9610270 View Registration
GAMBRO DIALYSATOREN GMBH Registration: 9611369 View Registration
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH Registration: 9611823 View Registration
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH Registration: 9611824 View Registration
Medica S.p.A. Registration: 9615942 View Registration

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Medical Device Recall: Z-0004-05

Recall Parameters & Description

Related Establishments / Registrations

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