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    Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·April 20, 2010

    TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·July 22, 2010

    026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FKX·April 28, 2021

    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

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    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).

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    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.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021

    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.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021

    (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.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021

    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.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·April 28, 2021

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    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. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

    FDA Recall
    Open, Classified ·Product code KWS·August 4, 2023

    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

    FDA Recall
    Open, Classified ·Product code LZO·August 4, 2023

    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

    FDA Recall
    Open, Classified ·Product code JWH·August 4, 2023

    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

    FDA Recall
    Open, Classified ·Product code KWA·August 4, 2023

    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101

    FDA Recall
    Open, Classified ·Product code PHX·August 4, 2023

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code KOD·September 20, 2022

    Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021