HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION solution, concentrate [AQUA MEDICA, S.A. DE C.V.]
Updated Date: Mon, 22 Nov 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 22, 2021 Category: Drugs & Pharmacology Source Type: alerts
Baxter Healthcare Corporation - PrixMax System - Class 2 Recall
Hemodialysis Delivery System, Software Version 2.x. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 12, 2021 Category: Medical Devices Source Type: alerts
TRIFERIC SOLUTION FOR HEMODIALYSIS (ferric pyrophosphate citrate) solution [Holopack Verpackungstechnik GmgH]
Updated Date: Mon, 01 Nov 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 1, 2021 Category: Drugs & Pharmacology Source Type: alerts
Fresenius Medical Care Holdings, Inc. - GranuFlo products (3 in total, all under K192209: item numbers 0FD22513B; 0FD32513B; 0FD32513B) - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2021 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Bibag (650 grams and 900 grams); item numbers: 084078BB and 084080BB - Class 2 Recall
(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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2021 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Holdings, Inc. - NaturaLyte Dry Bicarbonate Concentrate (item number: 0841122) - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2021 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Holdings, Inc. - NaturaLyte Liquid Acid Concentrate; item numbers: 0812511; 0822510; 0832519 - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2021 Category: Medical Devices Source Type: alerts
Medivators, Inc. - Dialysate Concentrate for HemodialysisLiquid/Powd - Class 2 Recall
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 16, 2021 Category: Medical Devices Source Type: alerts
HEMODIALYSIS SODIUM BICARBONATE solution, concentrate [Aqua Medica, S.A. de C.V.]
Updated Date: Thu, 03 Jun 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 3, 2021 Category: Drugs & Pharmacology Source Type: alerts
HEMODIALYSIS ACID CONCENTRATE solution, concentrate [Aqua Medica, S.A. de C.V.]
Updated Date: Thu, 03 Jun 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 3, 2021 Category: Drugs & Pharmacology Source Type: alerts
