Medical Device Recalls

Universal Tray Catalog 1567

Busse Hospital Disposables, Inc.

Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimensio

Siemens Healthcare Diagnostics, Inc.

RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2.

RAYSEARCH LABORATORIES AB

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

Heartware, Inc.

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Baxter Healthcare Corporation

FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter

Boston Scientific Corporation

VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102

Biomerieux Inc

DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A

Angiodynamics, Inc.

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354

Busse Hospital Disposables, Inc.

MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3

Mckesson Medical-Surgical Inc. Corporate Office

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113

Carefusion 2200 Inc

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline

Medline Industries, LP

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video du

Boston Scientific Corporation

CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators

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

3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape

3M Healthcare Business

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Ve

ASP Global, LLC.

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826

Datex-Ohmeda Inc

IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche

Omnicell, Inc.

Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

Skytron, Div. The KMW Group, Inc

Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accel

Inpeco S.A.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate

Philips North America Llc

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malign

Cordis Corporation

Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a

Cook Incorporated

MR 7700, Magnetic Resonance System.

Philips North America Llc

Access Substrate, REF 81906, For use with the Access Immunoassay Systems

Beckman Coulter, Inc.

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Chromsystems Instruments & Chemicals GmbH

Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

DiaSorin Molecular LLC