Medical Device Recalls

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Mode

Carwild Corporation

Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

Cardinal Health 200, LLC

Trevo Trak 21 Microcatheter, Catalog: 90338

Stryker Neurovascular

Alinity m Integrated Reaction Units (IRU)

Abbott Molecular, Inc.

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A

Medline Industries, LP

Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Bio

Medtronic Perfusion Systems

Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

Intersect ENT, Inc.

HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2

Thoratec Corp.

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as

Boston Scientific Corporation

LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

Physio-Control, Inc.

GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

Stradis Medical, LLC dba Stradis Healthcare

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

Cardinal Health

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus

Merit Medical Systems, Inc.

Centurion STERILE #16 RUBBER BAND, Product Code EB16

MEDLINE INDUSTRIES, LP - Northfield

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Smiths Medical ASD Inc.

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps a

MicroSurgical Technology Inc

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015

Stryker Corporation

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Foundation Medicine, Inc.

Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL

American Contract Systems Inc.

OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneL

Novapproach Spine LLC

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060

TELEFLEX LLC

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

VANTIVE US HEALTHCARE LLC

Philips S5-1 Transducer.

Philips Ultrasound, Inc

EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M005

Boston Scientific Corporation

Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

Randox Laboratories Ltd.

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65

TriMed Inc.

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

GE Medical Systems Information Technologies Inc