9 results
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63ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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WAVES WCM Kidney Cassette Module
FDA Recall
Terminated
·Waters Medical Systems LLC·Product code KDN·March 21, 2022
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, 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
HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes.
FDA Recall
Terminated
·Cenorin, LLC·Product code LDS·April 24, 2014
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
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
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
FDA Recall
Terminated
·Gentherm Medical, LLC·Product code DWC·June 17, 2021
Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC·Product code DWC·November 27, 2017
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code POZ·April 21, 2026