BAXTER HEALTHCARE CORPORATION - Kaguya Automated Peritoneal Dialysis System (T5C8500; only registered for distribution in Japan.) - Class 2 Recall
Kaguya Automated Peritoneal Dialysis System (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 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. - 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. - Sterile Stay Safe Cap (item number: 05095012) - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2021 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Cycler Drain Bag Set (item number: 02620226A) - Class 2 Recall
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....
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. - Fresenius APD LuerLock Adapter (item number: 05095018) - Class 2 Recall
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). (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
Avid Medical, Inc. - AVID / TruCustom DIALYSIS ACCESS kit - Class 1 Recall
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2021 Category: Medical Devices 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
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
