Medical Device Recalls

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

B Braun Medical Inc

Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610

GE Medical Systems, LLC

CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE

American Contract Systems Inc

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Medline Industries, LP

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B

Medline Industries, LP

ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submuco

Boston Scientific Corporation

MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A

Medline Industries, LP

BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9

CareFusion 303, Inc.

7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting

The Anspach Effort, Inc.

Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026,

GE Healthcare

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Changchun Wancheng Bio-Electron Co., Ltd.

Bivona Uncuffed Wire Endotracheal Tubes,

Smiths Medical ASD Inc.

Everest MI XT Outer Dilator, Catalog Number 5101-90168

K2M, Inc

Philips L8-4 Transducer.

Philips Ultrasound, Inc

Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and

Medtronic Neuromodulation

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quanti

Advance Dx, Inc.

CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator

Medtronic Inc.

ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY

Bard Peripheral Vascular Inc

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

Beckman Coulter Inc.

PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator

Inpeco S.A.

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A;

Sklar Instruments

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

Wilson-Cook Medical Inc.

Azurion IGTS Fixed Systems

Philips North America

Hobbs Scope Introducer Catalog Number: 4650

Hobbs Medical, Inc.

TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

PREMIA SPINE LTD

epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Siemens Healthcare Diagnostics Inc

HYDRATOME RX 44-30MM/450CM Material Number: M00583070

Boston Scientific Corporation

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product

Elekta, Inc.

X3 TRIATHLON CS INSERT NO 7 9 MM

Howmedica Osteonics Corp.

Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, P

MEDLINE INDUSTRIES, LP - Northfield