Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L. Reason for Recall: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer. Product Quantity: 101976 devices. Recall Number: Z-1409-2020. Code Information:

Study of 37,500 hemodialysis patient records provides compelling data on potential to reduce ESA use without impacting IV iron use or hemoglobin levels Data have clinical and cost implications given that more than 60 million hemodialysis sessions are completed in the U.S. every year1 Potential to drive savings of approximately $4.39 per hemodialysis session, or $660 per patient annually2

The Revaclear dialyzer series is a range of high efficiency high-flux dialyzers designed to enhance safety and biocompatibility for your patients, while optimizing clearance with a smaller surface area. 1 Revaclear 300 Dialyzer by Baxter Healthcare | Medline Industries, Inc. REVACLEAR 400 Dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. The REVACLEAR Dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis. For single use only.

Revaclear dialyzer

Rx Only. For safe and proper use of these devices refer to the device Instructions for Use. References 1. Revaclear, Revaclear MAX and Revaclear 300 and 400 Instructions for Use. 2. Revaclear Hemodialysis Dialyzer, US $ 4 - 7 / Piece, Jiangxi, China, Sanxin, 140L.Source from Jiangxi Sanxin Medtec Co., Ltd. on Alibaba.com. This item may require 1-2 days to ship out from our facility.Product Information: Revaclear 300 Dialyzer, Single UseManufacturer Part # 114745LDescription For treating chronic and acute renal failure by Hemodialysis Membrane made of polyarylethersulfone / polyvinylpyrrolidone (PAES/PVP) 300 mL saline priming volume; 74 Revaclear® 300 Polyaryl ethersulfone 1.4 300 48 Steam 272 256 242 174 323 298 278 191 1186 Revaclear® 300 Revaclear® 400 Polyaryl ethersulfone 1.8 300 54 Steam 281 267 255 191 338 315 297 213 1439 Revaclear® 400 Polyflux 6H Polyaryl ethersulfone 0.6 52 33 Steam 167 146 136 90 - - - - 465 Polyflux 6H Clearance at Qb 200, Qd 500 Polyflux 2H Revaclear Polyaryl ethersulfone 1.4 84 50 Steam 271 250 239 170 321 289 274 186 1167 Revaclear®300 Polyflux Revaclear MAX Polyaryl ethersulfone 1.8 100 60 Steam 282 265 256 191 339 311 297 211 1487 Revaclear®400 Asahi Kasei Medical Co. The Nephral ST dialyzer series features a heparin adsorptive hydrogel membrane for reduced use of heparin during dialysis. The membrane is designed to provide effective removal of uremic toxins and inflammatory mediators 4 while also reducing the systemic use of heparin.

Oct 10, 2018 Further, variability in observed clinical data in part reflects the lack of definition of test conditions. . The impact of different testing conditions on

107. 76. Jul 31, 2017 Dialyzers with a high Kuf need less TMP to achieve the same rate of ultrafiltration.

The applicability of a dialyzer for a particular treatment is the responsibility of the physician. In rare cases, thrombocytopenia or hypersensivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit may occur during hemodialysis.

REVACLEAR Dialyzers POLYFLUX 6H Dialyzer POLYFLUX 6H dialyzer is a high flux dialyzer for small patients including pediatric indications. 2019-08-15 · A recall of its Revaclear hemodialyzers in June will cost Baxter Renal Care around $20 million in lost revenues this year, company officials said during a recent second-quarter earnings call. and cause dialyzer reactions May be aggravated by use of ACEI AN-69 ST membranes: Coated with polycationic polymer to decrease reactions Heparin (negatively charged) can bind to the membrane The Polyflux Revaclear dialyzer is Gambro’s latest innovation in high-flux dialyzers. With modified membrane characteristics and a new dialyzer design, the Polyflux Revaclear dialyzer maintains Prescribed Dialyzer Brand in the U.S. Optiflux ® dialyzers continue to be the leading dialyzer brand in the United States, with more prescriptions filled than all other dialyzer manufacturers combined. Optiflux dialyzers are the time-tested choice for over twenty years for nephrologists seeking high performance, biocompatible dialyzers with 2019-06-03 · Baxter Healthcare Corporation sent letters to dialysis providers on May 31 saying it was voluntarily recalling certain lots of its Revaclear 300 and 400 model hemodialyzers due to blood leaks.

Product Quantity: 101976 devices.
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Product Quantity: 101976 devices. Recall Number: Z-1409-2020. Code Information: 2014-04-16 4 Methods Filter devices Two different mini-capillary dialyzer devices were obtained from Gambro Dialysatoren GmbH (Hechingen, Germany): 1) A high-flux membrane (Polyflux Revaclear ; HF-Revaclear ; n=12) with a total surface area of 360 cm2 and having a total number of 355 fibers, each of which with an inner diameter 190 µm, and a wall thickness of 35 µm (total intracapillary volume: 1.70 mL AccessGUDID - REVACLEAR (07332414124076)- Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis 2019-07-08 Device Name: Gambro Revaclear h 300 and 400 Dialyzer Common/Classification Dialyzer, high permeability with or without sealed dialysate Name: system Regulation Number: 21 CFll 876.5860 Product Code: KDI Review Panel: Gastroenterology / Urology Predicate Devices: Polyflux HD-C4 (BIG) (Revaclear Max) Cleared -April 24, 2006 K060 195 AccessGUDID - Revaclear (07332414114923)- Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis July 8, 2019 The FDA has announced a Class II recall of 59 lots of Baxter Revaclear 300 Dialyzer, Product Code 114745L, and 3 lots of Baxter Revaclear 400 Dialyzer, Product Code 114746L, totaling 1.3 million units. These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture.

Small changes in TMP in a high flux dialyzer can cause Kt/V Quick · Gambro Polyflux H Dialyzer Specifications · Gambro Revaclear Dialyzer Specifications · Fresenius Dialyzers · Hemoflow Dialyzers (Fresenius) Oct 28, 2019 When prescribing post-dilutional OL-HDF, the choice of the dialyzer HF dialyzers of comparable surface (the Phylther, the Revaclear 400 So back to this dialyzer insert(Revaclear) It contains a brief statement about the potential for accumulation of bicarbonate in the blood circuit Mar 8, 2020 FDA Recall Notice: Baxter Revaclear Dialyzer 300 -“There is the potential presence of particular matter in the header caps of ten lots the Aug 26, 2016 and the REVACLEAR dialyzer for hemodialysis (which uses a man-made filter) .
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So back to this dialyzer insert(Revaclear) It contains a brief statement about the potential for accumulation of bicarbonate in the blood circuit

Sales KIT REVACLEAR 400 CAPILLARY DIALYZER SINGLE USE. Item #:268720. Manufacturer: BAXTER RENAL DIVISION.