Medical Device Recalls

BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9

CareFusion 303, Inc.

BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166

CAREFUSION

stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Real

Tornier S.A.S.

Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:

Orthofix U.S. LLC

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

AVID Medical, Inc.

IntelePACS (Image Fusion Module) - InteleViewer

INTELERAD MEDICAL SYSTEMS INCORPORATED

Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty

Corin Ltd

EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795

Philips Ultrasound Inc

AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

Applied Medical Technology Inc

Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B

Medline Industries, LP

L12-5 50 Transducer Probe

Philips Ultrasound, Inc

Hamilton-C6

Hamilton Medical AG

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Graspe

Intuitive Surgical, Inc.

Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002

MEDLINE INDUSTRIES, LP - Northfield

BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3

Argon Medical Devices, Inc

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fr

Waldemar Link GmbH & Co. KG (Mfg Site)

SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

Siemens Medical Solutions USA, Inc.

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

Zimmer, Inc.

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123

Karl Storz Endoscopy

LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP

Bard Peripheral Vascular Inc

ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators

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

Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, C

Randox Laboratories Ltd.

ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators

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

ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators

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

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

Radiometer Medical ApS

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

Zimmer, Inc.

Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical

Medline Industries, LP

Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for inject

Cordis US Corp

B125P Patient Monitor (with E-module slot option), REF 6160000-002

GE Medical Systems, LLC

V9-2 Transducer Probe

Philips Ultrasound, Inc