Medical Device Recalls

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D

Carefree Surgical Specialties

This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configurati

Canon Medical System, USA, INC.

BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Clea

Mckesson Medical-Surgical Inc. Corporate Office

Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

GE Medical Systems, LLC

Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 So

United Orthopedic Corp.

WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

Boston Scientific Corporation

Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB

Cook Incorporated

VADER pedicle system, torque wrench, Catalog Number 42-702

Icotec Ag

VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Maquet Cardiovascular, LLC

BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4

Philips North America

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona

Siemens AG/Siemens Healthcare GmbH

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-657

TELEFLEX MEDICAL INC

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains

Ortho-Clinical Diagnostics, INc.

Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator

Hamilton Medical, Inc.

TENSIVE Conductive Adhesive Gel, REF 016-401600

Natus Neurology Inc

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D

Avanos Medical, Inc.

EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump

BERLIN HEART GMBH

Heraeus, PALAMIX uno. Material Number: 66057893.

Heraeus Medical GmbH (Dental Division)

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIA

Cardinal Health 200, LLC

Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

Preat Corp

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product De

Draeger, Inc.

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

Atrium Medical Corporation

Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Pr

Baxter Healthcare Corporation

Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-

Medline Industries, LP

nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR

Landauer

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP

3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Steril

Medical Modeling, Inc.

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in

Philips North America Llc

Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB

American Contract Systems, Inc.