Medical Device Recalls

BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D

CAREFUSION

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308

Howmedica Osteonics Corp.

Flow-i C20 Anesthesia System, model 6677200

Getinge Usa Sales Inc

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for

Angiodynamics, Inc.

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat

Abiomed, Inc.

1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG

MEDLINE INDUSTRIES, LP - Northfield

TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo

Howmedica Osteonics Corp.

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Mevion Medical Systems, Inc.

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):

Philips North America

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297

MICROVENTION INC.

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Roche Diagnostics Operations, Inc.

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

Boston Scientific Corporation

Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K

Medline Industries, LP

ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

VentStar Anesthesia (N) 180, MP00333

Draeger Medical, Inc.

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen

Meridian Bioscience Inc

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050

TELEFLEX LLC

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650

Mentor Texas, LP.

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,

Spectranetics Corporation

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, a

Stryker Corporation

Gentueri Viral Transport Medium (VTM), Sterile, IVD

Gentueri Inc

Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

ROi CPS LLC

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

Medline Industries, LP

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Abbott Laboratories

Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and he

Siemens Healthcare Diagnostics, Inc.

CombiDiagnost R90 1.1 (709031)

PHILIPS MEDICAL SYSTEMS

Philips 3D9-3v Transducer.

Philips Ultrasound, Inc

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

AVID Medical, Inc.

Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Mirion Technologies (Capintec), Inc.