Medical Device Recalls

Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905

Medline Industries, LP

Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and i

Scientia Vascular, Inc.

Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic d

Philips North America Llc

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter

Boston Scientific Corporation

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX

W L Gore & Associates, Inc.

ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262

Biomerieux Inc

Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati

Datex-Ohmeda, Inc.

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10

Maquet Medical Systems USA

Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

Maquet Cardiopulmonary Gmbh

Ureteral dilator, REF RBD014

Coloplast Manufacturing US, LLC

DeRoyal EYE TRAY PGYBK, REF 89-7978.02

DeRoyal Industries Inc

MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

Medtronic MiniMed, Inc.

Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K

Boston Scientific Neuromodulation Corporation

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADUL

MEDLINE INDUSTRIES, LP - Northfield

SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous

Synthes (USA) Products LLC

Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in t

Datascope Corp.

WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.

WOM World Of Medicine AG

CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through t

Maquet Medical Systems USA

Plum Duo Infusion Pump, 40002-0401

ICU Medical, Inc.

Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulm

Spectrum Medical Inc

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

Katalyst Surgical, LLC

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresen

Fresenius Medical Care Holdings, Inc.

Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc.

VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341

Biomerieux Inc

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

B Braun Medical Inc

PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU

ARROW INTERNATIONAL, LLC

Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

Medtronic Xomed, Inc.

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail

Smith & Nephew, Inc.