Fresenius Medical Care Renal Therapies Group, LLC - Fresenius 132 Gallon Dry Acid Dissolution Unit - Class 2 Recall
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius 132 Gallon GranuFlo Dissolution Unit - Class 2 Recall
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Naturalyte Liquid Bicarbonate Concentrate - Class 2 Recall
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2015 Category: Medical Equipment Source Type: alerts
Covidien LLC - Palindrome SI Chronic Catheter Kit - Class 2 Recall
Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 1, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius NaturaLyte - Class 2 Recall
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 23, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius 2008K Dialysate Delivery System - Class 2 Recall
2008¿ Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - 2008T Hemodialysis Machine - Class 2 Recall
2008¿ Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K @ Home System - 1st Gen. -¿ Canada; 190828 2008K @ Home System - 2nd Gen - U.S.; 190904 2008K @ Home System w/ Bibag; 190828 2008K@HOME HEMODIALYSIS SYSTEM; 190395 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius 2008Khome Hemodialysis Machine with bibag System - Class 2 Recall
2008¿ Series Hemodialysis Machines: 2008K@home - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius 2008K Dialysate Delivery System - Class 2 Recall
2008¿¿ Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC & Diasafe Plus); 190300 2008K System Std (w/OLC & Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC & Diasafe Plus - Spanish; 190302 2008K System w/ OLC & Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC & Diasafe; 190304 2008K System w/o OLC & Diasafe & HP; ...
Source: Medical Device Recalls - April 30, 2015 Category: Medical Equipment Source Type: alerts
Medical Components, Inc dba MedComp - Various catheters marketed by Medcomp and AngioDynamics - Class 2 Recall
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 31, 2015 Category: Medical Equipment Source Type: alerts
Transonic Systems Inc - Transonic Hemodialysis Monitor - Class 2 Recall
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2015 Category: Medical Equipment Source Type: alerts
Medical Components, Inc dba MedComp - HEMOCATH, SLX, PROPICC, VASCUPICC - Class 2 Recall
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intra...
Source: Medical Device Recalls - February 11, 2015 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius ASSEMBLY, POWER SUPPLY - Class 2 Recall
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2015 Category: Medical Equipment Source Type: alerts
Arrow International Inc - Class 2 Recall
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis. (So...
Source: Medical Device Recalls - January 23, 2015 Category: Medical Equipment Source Type: alerts
Gambro Renal Products Inc - Polyflux Revaclear - Class 2 Recall
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2014 Category: Medical Equipment Source Type: alerts
