Medical Device Recalls

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/

Medline Industries, LP

Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6

Baxter Healthcare Corporation

Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagul

Medtronic Navigation, Inc.

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

TELEFLEX LLC

QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR reade

Landauer

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:

Integra LifeSciences Corp.

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surg

Carefusion 2200 Inc

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent

Siemens Medical Solutions USA, Inc

Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

St. Jude Medical, Cardiac Rhythm Management Division

GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20,

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

Olympus Corporation of the Americas

(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator

MEDLINE INDUSTRIES, LP - Northfield

Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

Randox Laboratories Ltd.

SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

PATH

GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

DeRoyal Industries Inc

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

Olympus Corporation of the Americas

FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015

Mckesson Medical-Surgical Inc. Corporate Office

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060

TELEFLEX LLC

Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

Covidien, LP

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, R

RAYSEARCH LABORATORIES AB

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;

Beaver Visitec International, Inc.

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

Heartware, Inc.

S7-3t Transducer Probe

Philips Ultrasound, Inc

Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Pr

TISSIUM SA

Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

MEDLINE INDUSTRIES, LP - Northfield

AirTouch F20 Full Face Mask and User Guide

ResMed Ltd.

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary

St. Jude Medical

ICU Medical ChemoLock Port REF: CL2100

ICU Medical, Inc.

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product

Elekta, Inc.

Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

AVID Medical, Inc.