BEUDAMED
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    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code FIP·January 24, 2023

    MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages

    FDA Recall
    Terminated ·U.S. Filter/Ionpure, Inc.·Product code FIP·February 28, 2005

    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FIP·September 1, 2020

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·April 24, 2014

    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

    FDA Recall
    Terminated ·AmeriWater Inc·Product code FIP·August 9, 2012

    AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 16, 2022

    AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FIP·August 3, 2021

    US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·May 16, 2024

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

    FDA Recall
    Terminated ·Ameriwater Inc·Product code FIP·September 3, 2004

    AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius Part Number: G02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ USA G02040120FMC-US AquaBplus HF- Typ USA

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FIP·March 18, 2021

    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 16, 2022

    AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022

    Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen Dx Single Dip Card Single Drug Detection: Oxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx Single Dip Card Single Drug Detection: Benzodiazepine (BZO300)", X11-IS1 MET-DX / "Alere iScreen Dx Single Dip Card Single Drug Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",

    FDA Recall
    Terminated ·Ameditech Inc·Product code DIO·August 18, 2020

    VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014

    ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014

    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014