1,829 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FKX·April 28, 2021
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock connector (e.g., Liberty cycler, Newton IQO cycler).
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Recall
Terminated
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·November 11, 2020
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·May 22, 2020
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·September 28, 2017
Movable Core Wire Guide
FDA Recall
Terminated
·Cook Inc.·Product code DQX·October 13, 2017
Double Flexible Tipped Wire Guide
FDA Recall
Terminated
·Cook Inc.·Product code DQX·October 13, 2017
Amplatz Extra Stiff Wire Guide
FDA Recall
Terminated
·Cook Inc.·Product code DQX·October 13, 2017
Central Venous Catheter Tray
FDA Recall
Terminated
·Cook Inc.·Product code DQY·October 13, 2017
Bentson Wire Guide
FDA Recall
Terminated
·Cook Inc.·Product code DQX·October 13, 2017
Fixed Core Bentson
FDA Recall
Terminated
·Cook Inc.·Product code DQX·October 13, 2017
TFE Coated Curved Newton LLT
FDA Recall
Terminated
·Cook Inc.·Product code DQX·October 13, 2017