Medical Device Recalls

GEM Premier 5000; Part No. 00055445010 & 00055445011.

Instrumentation Laboratory

Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to

Siemens Healthcare Diagnostics, Inc.

FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926

Full Vision Inc

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

Integra LifeSciences Corp.

DeRoyal GU PACK, REF 89-10665.02

DeRoyal Industries Inc

TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284

Edwards Lifesciences, LLC

Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY

MEDLINE INDUSTRIES, LP - Northfield

IDM-MULTI-R. Electrical wheelchair component.

mo-Vis BVBA

Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSI

MEDLINE INDUSTRIES, LP - Northfield

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

Philips North America Llc

Centurion PICC LINE SECUREMENT KIT, Product Code IVS565

MEDLINE INDUSTRIES, LP - Northfield

(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta

CareFusion 303, Inc.

Intera 1.5T Omni/Stellar; Product Number: 781104;

Philips North America

X80 RADiant Photoelectric Therapy System

Xstrahl Limited

FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Men s Hormone Test

GET TESTED INTERNATIONAL AB

VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982

Biomerieux Inc

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

Windstone Medical Packaging, Inc.

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fra

Tyber Medical

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

MicroPort Orthopedics Inc.

stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

Tornier S.A.S.

Merlin 2 PCS MER3700 programmer Model MER3400 software

St. Jude Medical, Cardiac Rhythm Management Division

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001545;

Beaver Visitec International, Inc.

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf

Micro Therapeutics, Inc.

Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

Cepheid

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xp

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343

Biomerieux Inc

Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3

MEDLINE INDUSTRIES, LP - Northfield