Baxter Healthcare Corporation - Amia Automated PD Set with Cassette - Class 2 Recall
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2023 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Automated Peritoneal Dialysis System - Class 2 Recall
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2023 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - MiniCap Disconnect Caps - Class 2 Recall
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2023 Category: Medical Devices Source Type: alerts

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. - 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. - 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. - 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 Renal Therapies Group, LLC - Class 2 Recall
Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2019 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - AMIA Automated Peritoneal Dialysis Cycler - Class 2 Recall
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2019 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Kaguya Automated Peritoneal Dialysis System - Class 2 Recall
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2019 Category: Medical Devices Source Type: alerts

Merit Medical Systems, Inc. - FlexNeck Classic Peritoneal Dialysis Catheter (Pediatric) - Class 2 Recall
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC¿ System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adh...
Source: Medical Device Recalls - August 16, 2018 Category: Medical Devices Source Type: alerts

Fresenius Medical Care Renal Therapies Group, LLC - Liberty Select Cycler - Class 2 Recall
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2018 Category: Medical Devices Source Type: alerts

Merit Medical Systems, Inc. - Custom Dialysis Kit CF4230 Without Gel - Class 2 Recall
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2018 Category: Medical Devices Source Type: alerts

Merit Medical Systems, Inc. - FlexNeck Classic Peritoneal Dialysis Catheter - Class 2 Recall
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2018 Category: Medical Devices Source Type: alerts

Merit Medical Systems, Inc. - Custom Dialysis Kit CF4235 Without Gel - Class 2 Recall
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2018 Category: Medical Devices Source Type: alerts