Medical Device Recalls

PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU

Heartware, Inc.

Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Folsom Metal Products, Inc.

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

Siemens Healthcare Diagnostics Inc

Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vect

MED-EL Elektromedizinische Gereate, Gmbh

FoundationOne Companion Diagnostic (F1CDx)

Foundation Medicine, Inc.

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Cypress Medical Products LLC

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imag

GE Healthcare, LLC

GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO

DJO, LLC

GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2)

Cardinal Health 200, LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001809;

Beaver Visitec International, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584727;

Beaver Visitec International, Inc.

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endos

Olympus Corporation of the Americas

SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in p

Integra LifeSciences Corp.

DigitalDiagnost C90, Model No. 712034 and 712035

Philips North America Llc

Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A

SunMed Holdings, LLC

BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

Becton Dickinson & Co.

Organic acids Test

GET TESTED INTERNATIONAL AB

HeartWare HVAD Driveline Extension Cable, REF 100US

Heartware, Inc.

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL

Baxter Healthcare Corporation

Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

Cardinal Health 200, LLC

DeRoyal BIOPSY PACK, REF 89-9270.04

DeRoyal Industries Inc

Campy CVA Medium 100/PK, R01272

Remel, Inc

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

Boston Scientific Corporation

Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialys

Baxter Healthcare Corporation

VariSoft infusion set, Model Number 1002827

Unomedical A/S

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

MEDLINE INDUSTRIES, LP - Northfield

ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stab

Zimmer, Inc.

Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

Jewel Precision Sheet Metal & Machining Co, Inc.

TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate

Tytek Medical Inc