Arrow International Inc - ARROWgard Blue CVC Kit - Class 2 Recall
ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 11, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - 2008 Series Hemodialysis Machine - Class 2 Recall
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 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. - 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
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
NxStage Medical, Inc. - Premixed Dialysate for Hemodialysis - Class 2 Recall
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - NaturaLyte Liquid Acid - Class 2 Recall
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This 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 - March 15, 2018 Category: Medical Devices Source Type: alerts
Medtronic Minimally Invasive Therapies Group - MAHURKAR Elite 12 FR x 16cm Acute Dual Lumen Dialysis - Class 2 Recall
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Subsystem, proportioning - Class 2 Recall
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - 2008T Hemodialysis Delivery System - Class 2 Recall
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - ARROWgard Blue - Class 2 Recall
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
RENAL CAPS DIALYSIS/STRESS VITAMIN SUPPLEMENT (Ascorbic Acid, Thiamine Mononitrate,Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, ) Capsule, Liquid Filled [Cypress Pharmaceutical, Inc.]
Updated Date: Jan 8, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 8, 2018 Category: Drugs & Pharmacology Source Type: alerts
Baxter Healthcare Corp - Baxter Amia Automated Peritoneal Dialysis Set with Cassette - Class 2 Recall
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2017 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - HomeChoice Automated PD system - Class 2 Recall
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2017 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - HomeChoice Automated PD system - Class 2 Recall
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2017 Category: Medical Devices Source Type: alerts
