Medical Device Recalls

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre

Thoratec LLC

Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06

AVID Medical, Inc.

Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

Baxter Healthcare Corporation

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

2008T GEN 2 Bibag without CDX

Fresenius Medical Care Holdings, Inc.

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators

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

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Abbott

Therapy Mask 3100 NC/SP

Philips Respironics, Inc.

HeartWare HVAD Pump Kit, REF MCS1705PU

Heartware, Inc.

Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L

Medline Industries, LP

NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-

NxStage Medical Inc

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12

Edan Diagnostics

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;

Beaver Visitec International, Inc.

NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701

Stradis Medical, LLC dba Stradis Healthcare

Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7

Medtronic MiniMed, Inc.

BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)

Synergetics Inc

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respirat

Maquet Medical Systems USA

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

GE Medical Systems, LLC

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fr

Waldemar Link GmbH & Co. KG (Mfg Site)

6IN PRESSURE TUBING, List Number MX20617

Smiths Medical Asd Inc

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Covidien Llc

Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Le

Microbiologics Inc

Ziehm Vision FD. Interventional fluoroscopic x-ray system

Orthoscan, Inc.

Phoenix mKDR, digital mobile diagnostic x-ray system

SEDECAL SA

ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013

Biomerieux Inc

EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) si

Philips North America Llc

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570

Busse Hospital Disposables, Inc.

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Ossur Americas

MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;

Philips North America