Medical Device Recalls

P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307

Howmedica Osteonics Corp.

RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatio

RAYSEARCH LABORATORIES AB

Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, P

MEDLINE INDUSTRIES, LP - Northfield

MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product

Megadyne Medical Products, Inc.

The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/

Randox Laboratories Ltd.

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05

Merit Medical Systems, Inc.

Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

Cordis Corporation

Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible w

Olympus Corporation of the Americas

MiniMed insulin pump, REF: 620G (MMT-1750)

Medtronic MiniMed, Inc.

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software

Olympus Corporation of the Americas

VITROS 3600 Immunodiagnostic System (New and Refurbished)

Ortho-Clinical Diagnostics, Inc.

Horizon Cardiology Hemo. Version 12.2.

CHANGE HEALTHCARE CANADA COMPANY

OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X

Novapproach Spine, LLC

Model No. CYF-5R, Cystonephrofiberscope

Shirakawa Olympus Co., Ltd.

HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03

Covidien LLC

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes a

Boston Scientific Corporation

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, T

Alphatec Spine, Inc.

Baxter Operating Table TruSystem 7000, Product code REF 1841046

Baxter Healthcare Corporation

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Civco Medical Instruments Co. Inc.

REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number:

Howmedica Osteonics Corp.

Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label

Stryker Instruments Div. of Stryker Corporation

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

Smith & Nephew, Inc.

Octopus Evolution Tissue Stabilizer, Model TS2000

Medtronic Perfusion Systems

LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

LSL Healthcare Inc.

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of

Boston Scientific Corporation

CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG

American Contract Systems Inc

DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

Beckman Coulter, Inc.

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Delta Med SpA

Allura Xper FD20; Model Number: 722012;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.