Medical Device Recalls

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF

EITAN MEDICAL LTD

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151

ARROW INTERNATIONAL, LLC

Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090

ARROW INTERNATIONAL, LLC

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product

Olympus Corporation of the Americas

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

ARROW INTERNATIONAL Inc.

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventi

Siemens Medical Solutions USA, Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825;

Beaver Visitec International, Inc.

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3

GE Healthcare, LLC

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Mode

MEDLINE INDUSTRIES, LP - Northfield

BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1

CareFusion 303, Inc.

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

Becton Dickinson Infusion Therapy Systems, Inc.

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

Vortex Surgical Inc.

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49

Medtronic Vascular, Inc.

SmartPath to dStream for 1.5T¿; Product Number: 782146;

Philips North America

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190

Cardinal Health 200, LLC

HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F

American Contract Systems Inc

Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)

CooperSurgical, Inc.

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultan

Philips North America Llc

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Numbe

Encore Medical, LP

CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6S

Carefusion 2200 Inc

Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

Wright Medical Technology, Inc.

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

Boston Scientific Corporation

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Epimed International

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

Philips North America Llc

NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

Baxter Healthcare Corporation

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

Stryker Medical Division of Stryker Corporation

Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co

Mindray DS USA, Inc. dba Mindray North America

Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

Remel Inc