Medical Device Recalls

Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4;

ARROW INTERNATIONAL, LLC

CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators

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

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization

Medtronic Sofamor Danek USA Inc

GS70 Salus Surgical Table, Product Code 18-070-70

Skytron, LLC

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

B Braun Medical Inc

Oncentra Brachy radiation therapy planning system software.

Elekta, Inc.

Cholesterol Test

GET TESTED INTERNATIONAL AB

3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal

3M Company - Health Care Business

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M;

Sklar Instruments

Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive

Mckesson Medical-Surgical Inc. Corporate Office

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Siemens Medical Solutions USA, Inc

IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, P

Stryker Medical Division of Stryker Corporation

Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11

AVID Medical, Inc.

Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTB

Medtronic Inc.

Iron Deficiency Test (ferritin)

GET TESTED INTERNATIONAL AB

MAGNETOM Connectom.X. Model Number: 11371480.

Siemens Medical Solutions USA, Inc

BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9

CareFusion 303, Inc.

Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440

Olympus Corporation of the Americas

PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z

ETHICON, LLC

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

Olympus Corporation of the Americas

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS i

Edan Diagnostics

Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic proced

Aizu Olympus Co., Ltd.

ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

ICU Medical, Inc.

Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instru

Nextremity Solutions

Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors

Steris Corporation

VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500

Maquet Cardiovascular, LLC

Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100

MEDLINE INDUSTRIES, LP - Northfield

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

Brasseler USA I Lp

TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

Howmedica Osteonics Corp.

Colonoscope, Model Number PCF-HQ190L.

Olympus Corporation of the Americas