Medical Device Recalls

Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-

Cook Incorporated

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

B Braun Medical Inc

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095

TELEFLEX LLC

Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

Fisher & Paykel Healthcare, Ltd.

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:

Medline Industries, LP

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

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Biodex Medical Systems, Inc.

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

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.

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319,

Abbott Molecular, Inc.

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