Medical Device Recalls

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Biomerieux Inc

PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,

Entopsis , Inc.

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

C.R. Bard Inc

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

GE Medical Systems, LLC

Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of

Baxter Healthcare Corporation

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Civco Medical Instruments Co. Inc.

LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022

Physio-Control, Inc.

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC

Cordis US Corp

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of

Boston Scientific Corporation

Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for pr

Olympus Corporation of the Americas

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not

ARROW INTERNATIONAL Inc.

BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9

CareFusion 303, Inc.

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump

ARROW INTERNATIONAL Inc.

Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

Baxter Healthcare Corporation

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Howmedica Osteonics Corp.

Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4

Cook Incorporated

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/

Angiodynamics, Inc.

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

O&M HALYARD, INC.

Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

DePuy Orthopaedics, Inc.

Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025

Beaver Visitec International, Inc.

ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators

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

Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

Medline Industries, LP

C5-2 Lumify Transducer Probe

Philips Ultrasound, Inc

ProCuity bed series, model number 3009, item number: 3009PX-LE-400.

Stryker Medical Division of Stryker Corporation

Spectrum IQ Infusion Pump, Product Code 3570009

Baxter Healthcare Corporation

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Hobbs Medical, Inc.

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

Illumina, Inc.

Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer

Boston Scientific Corporation

CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators

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

ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capa

ZOLL Circulation, Inc.