Medical Components, Inc dba MedComp - American Access; Nikkiso; Lifeline - Class 2 Recall
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 26, 2018 Category: Medical Devices Source Type: alerts
Medical Components, Inc dba MedComp - American Access; Nikkiso; Lifeline - Class 2 Recall
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 26, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - VPS TipTracker Stylet Accessory - Class 2 Recall
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis ...
Source: Medical Device Recalls - July 9, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - Peripherally Inserted Midline Catheter Kit with Placement Wire - Class 2 Recall
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SV...
Source: Medical Device Recalls - July 9, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - VPS Rhythm ECG Accessory Pack with Johans Adapter - Class 2 Recall
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chro...
Source: Medical Device Recalls - July 9, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - VPS Rhythm ECG Accessory Pack - Class 2 Recall
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis cat...
Source: Medical Device Recalls - July 9, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - NaturaLyte Liquid Acid Concentrate - Class 2 Recall
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: 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. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
Nipro Medical Corporation - Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film - Class 2 Recall
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
Rockwell Medical, Inc - DriSate - Class 2 Recall
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts
Transonic Systems Inc - Transonic ADT 1018 Flow QC Clear Advantage Tubing - Class 2 Recall
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 10, 2018 Category: Medical Devices Source Type: alerts
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
Arrow International Inc - ARROWgard Blue TwoLumen Hemodialysis Catheterization Kit - Class 2 Recall
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 11, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - AGB Multi Lumen Central Venous Catheterization (CVC) Kit - Class 2 Recall
AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A; (8) CDA-42703-P1A; AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A; (10) AK-45854-P1A; AGB+ Two Lumen CVC Kit (11) AK-42802-P1A; (12) AK-45802-P1A; (13) AK-46702-P1A; (14) AK-47702-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A; ARR...
Source: Medical Device Recalls - April 11, 2018 Category: Medical Devices Source Type: alerts
Arrow International Inc - MultiLumen Hemodialysis Catheterization Kit - Class 2 Recall
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A (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
