Medical Device Recalls

3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A

KCI USA, INC.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy S

Noah Medical Corporation

Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

Beckman Coulter, Inc.

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, N

Ortho8, Inc.

BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

Becton Dickinson & Company

EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adult

Olympus Corporation of the Americas

Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS

Medline Industries, LP

Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

ACTIM OY

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-E

Northeast Scientific Inc.

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Medtronic Navigation, Inc.-Boxborough

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-

Northeast Scientific Inc.

Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB

Getinge Usa Sales Inc

nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR re

Landauer

Yeastone Broth, 11ML, 10/BOX YY3462

Remel, Inc

Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

MEDLINE INDUSTRIES, LP - Northfield

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

Cardinal Health 200, LLC

MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047

Mckesson Medical-Surgical Inc. Corporate Office

SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

Covidien, LP

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF,

MEDLINE INDUSTRIES, LP - Northfield

CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers

Landauer

Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele

Abbott Medical

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NE

Cook Incorporated

NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

Delta Med SpA

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

Boston Scientific Corporation

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

Siemens Healthcare Diagnostics, Inc.

ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A

American Contract Systems Inc

Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatme

Getinge Usa Sales Inc

Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Ac

Corin Ltd