Medical Device Recalls

2011 Medical Device Recalls (Listed Alphabetically by Manufacturer)medical device recalls

If you would like more information on these and other medical device recalls, please visit the FDA Website.

A

Abbott Glucose Recalls Test Strips (February 15, 2011)
AngioScore Inc. Recalls AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018" Platform (multiple sizes) (January 1, 2011)
Arrow International, Inc. Recalls Arrow NextStep Antegrade Chronic Hemodialysis Catheter (August 3, 2011)
Arrow Recalls Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System: (January 26, 2011)
Arstasis Recalls One Access System (February 9, 2011)

B

B. Braun Recalls Outlook 400ES Safety Infusion System, Model Number 621-400ES (January 31, 2011)
Beckman Coulter, Inc. Recalls Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell (May 23, 2011)
bioMérieux, Inc. Expands Recall of VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP2) (May 3, 2011)
Boston Scientific Recalls Innova Self-Expanding Stent System (June 16, 2011)
Boston Scientific Recalls iCross and Atlantis SR Pro 2 Coronary Imaging Catheters (June 14, 2011)

C

Churchill Medical Systems, a Vygon Company, Recalls Skin-Prep Wipes Used in Convenience Kits and Tray (June 15, 2011)
Cook Inc. Recalls Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays (March 3, 2011)

D

Davol Inc. Recalls XenMatrix Surgical Graft (March 4, 2011)
Defibtech LLC Recalls Lifeline and ReviveR AEDs: Software Defect May Cancel Shock (May 10, 2011)

E

F

Fresenius Medical Care North America Recalls CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor (January 20, 2011)

G

GE Healthcare Recalls Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits (August 3, 2011)
GEM Recalls Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System (August 1, 2011)
Gen-Probe Inc. Recalls AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test, and AccuProbe Mycobacterium Avium Complex Culture Identification Test (March 17, 2011)
Global Focus Marketing & Distribution, Ltd. Recalls Silencer® S2200 Centrifuge (July 27, 2011)

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iCAD, formerly Xoft Inc., Recalls Axxent® FlexiShield Mini, Model F5300 (April 13, 2011)

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Lee Medical International Inc. Recalls Custom Dialysis Trays/Kits (October 3, 2011)
Lee Medical International Inc. Recalls Custom Dialysis Trays/Kits (September 16, 2011)

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Maquet Cardiovascular, LLC Recalls Heartstring II Proximal Seal System (HS-1045) (March 31, 2011)
Maquet Datascope Corp. Recalls Intra-Aortic Balloon Pumps (June 14, 2011)
Medtronic Recalls Model 8637 SynchroMed II Implantable Infusion Pump (September 12, 2011)
Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits (February 16, 2011)
Merit Medical Systems Recalls Prelude Short Sheath Catheter Introducer (February 4, 2011)
Millar Instruments Inc. Recalls Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F (March 31, 2011)

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Oridion Medical and Philips Healthcare Recall Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate) (June 6, 2011)

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Penumbra Inc. Recalls Penumbra Coil 400 (April 13, 2011)

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Roche Diagnostics Operations Recalls ACCU-CHEK Performa Strip (June 20, 2011)
Roche Insulin Delivery Systems, Recalls ACCU-CHEK FlexLink Plus Infusion Sets (March 29, 2011)

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Terumo Recalls Coronary Ostia Cannula Sizes 10, 12, 14 (June 14, 2011)
Triad Group Recalls Triad Sterile Lubricating Jelly (February 15, 2011)

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2010 Medical Device Recalls (Listed Alphabetically by Manufacturer)

A

Abiomed, Inc. Recalls AB5000 Circulatory Support System (March 10, 2010)
Alcon Research LTD, a/k/a Alcon Laboratories, Inc. Recalls CONSTELLATION Vision System (July 20, 2010)
AngioScore Inc. Recalls AngioSculpt "EX" PTCA Scoring Balloon Catheter (September 8, 2010)

B

B. Braun Recalls addEASE Binary Connector (November 30, 2010)
Baxter Recalls Colleague Single and Triple Channel Volumetric Infusion Pumps - Recall, Refund and Replacement (November 30, 2010)
Baxter Recalls HomeChoice and HomeChoice PRO (March 3, 2010)
Baylis Medical Company Inc. Recalls Torflex Transseptal Guiding Sheath (March 11, 2010)
Beckman Coulter Inc. Recalls UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell (March 10, 2010)
Becton, Dickinson (BD) and Company Recalls Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc. (March 30, 2010)
bioMérieux, Inc. Recalls VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP) (November 10, 2010)

C

Cardiac Science Corporation Recalls Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs) (April 30, 2010)
Cardiac Science Corporation Recalls Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs) (March 8, 2010)
CareFusion Corporation Recalls Alaris PC Units (Model 8015) (October 15, 2010)
Cepheid Recalls Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System (July 2, 2010)
Cook Medical Recalls Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube (August 4, 2010)

D

Defibtech LLC Recalls DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators (June 14, 2010)

E

Edwards Lifesciences Inc. Recalls Aquarius Hemodialysis System (January 28, 2010)
ev3 Endovascular, Inc. Recalls NanoCross .014" OTW PTA Dilatation Catheter (December 28, 2010)
ev3 Endovascular, Inc. Recalls Trailblazer Support Catheter (January 5, 2010)
Excelsior Medical Recalls Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe) (October 26, 2010)
Exelint International Inc. Recalls Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets (February 26, 2010)

F

Fresenius Kabi LLC Recalls Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices (December 21, 2010)

G

GE Healthcare Recalls Aisys and Avance Anesthesia Systems (May 17, 2010)
Gyrus ACMI, Inc. Recalls Micron Bobbin Vent Tube T, 1.27 mm (March 17, 2010)

H

Hettich Instruments Recalls Hettich Centrifuges with 2050 and 2076 Plastic Rotors (January 28, 2010)
Hospira Recalls Symbiq One and Two Channel Infuser (November 4, 2010)

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Ikaria Holdings Recalls INOMAX DS Drug Delivery System (August 23, 2010)

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Medtronic Recalls Octopus Nuvo Tissue Stabilizer, Model TSMICS1 (November 2, 2010)
Micromedics, Inc. Recalls Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes – Sealed in Pouches (November 23, 2010)
Multi-Med, Inc. Recalls 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls) (August 26, 2010)

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Nellcor Recall of Certain Cuffed Shiley Tracheostomy Tubes (May 17, 2010)

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Penumbra Recalls Penumbra System Reperfusion Catheter 032 (December 8, 2010)
Physio-Control Inc. Recalls LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors (July 2, 2010)
Physio-Control Inc. Recalls LIFEPAK 15 Monitor/Defibrillator (April 22, 2010)

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SIGMA Recalls Spectrum Infusion Pump Model 35700 (November 12, 2010)
St. Jude Medical Recalls 6 French Engage™ Introducer Devices (August 13, 2010)
StatSpin, Inc., doing business as IRIS Sample Processing Recalls StatSpin Express 4 Centrifuges, Model #510 (February 26, 2010)
Symbiq Recalls One- and Two-Channel Infusers (September 21, 2010)
Symbiq Recalls One- and Two-Channel Infusers (July 15, 2010)

T

Teleflex Incorporated Recalls Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters (April 8, 2010)
Thomas Medical Products Inc. Recalls Transseptal Sheath Introducer Kits (March 8, 2010)
Thomas Medical Products Inc. Recalls Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport (February 4, 2010)

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WalkMed, Inc. Recalls Triton Pole Mount Infusion Pump (November 24, 2010)
Westmed Inc. Recalls BagEasy Manual Resuscitation Devices (October 13, 2010)

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2009 Medical Device Recalls (Listed Alphabetically by Manufacturer)

A

Abbott Vascular-Cardiac Therapies, doing business as Guidant Corporation, Recalls POWERSAIL Coronary Dilatation Catheters (August 6, 2009)

B

Baxter Recalls Colleague Single and Triple Channel Volumetric Infusion Pumps (March 11, 2009)
Biosite Incorporated Recalls Triage Cardiac Panel (May 7, 2009)

C

Cardinal Health Recalls Various Modules of the Alaris System (August 5, 2009)
Cardiovascular Systems, Inc. Recalls ViperSheath Sheath Introducer (December 3, 2009)
Centurion Medical Products Recalls Premie Pack and Meconium Pack (November 4, 2009)
ConMed Linvatec Recalls Power Pro Handpieces (September 10, 2009)
ConMed Linvatec Recalls Universal Cables (September 10, 2009)
ConvaTec, doing business as Unomedical, Inc., Recalls Manual Pulmonary Resuscitator (MPR) (Single-Patient Use) (November 3, 2009)
Cordis Corporation Recalls CROSSOVER Sheath Introducer (December 23, 2009)
Covidien Inc. Recalls Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube (March 9, 2009)
Covidien Inc. Recalls Pedi-Cap End-Tidal CO2 Detector (September 10, 2009)

D

Draeger Medical Inc. Recalls Stabilet Infant Warmer (August 25, 2009)

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Edwards Lifesciences Corporation Recalls CardioVations EndoClamp Aortic Catheter (November 9, 2009)

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Luv N' Care Recalls Gel-Filled Teethers – "Nuby," "Cottontails," and "Playschool" Models (August 12, 2009)

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Medtronic Inc. Recalls MiniMed Paradigm Quick-Set Infusion Sets (July 21, 2009)
Medtronic Inc. Recalls Kappa 600/700/900 Series of Pacemakers and Sigma 100/200/300 Series of Pacemakers (June 12, 2009)
Medtronic Neurologic Technologies Recalls Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide (March 27, 2009)
Medtronic Neuromodulation Recalls INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit (September 24, 2009)

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Penumbra Inc. Recalls Neuron 5F Select Catheter (September 9, 2009)
Penumbra, Inc. Recalls Neuron 6F 070 Delivery Catheter (Original Version) (October 7, 2009)
Physio-Control Inc. Recalls LIFEPAK CR Plus Automated External Defibrillators (AEDs) (September 16, 2009)
Pointe Scientific, Inc. Recalls Liquid Glucose Hexokinase Reagent (G7517) (November 6, 2009)

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Respironics, Inc. Recalls SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003) (May 18, 2009)

S

Smiths Medical ASD, Inc. Recalls Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0, and 3.5 mm) (September 21, 2009)
Stryker Corporation Instrument Division Recalls Operating Room System II Surgical Navigation Systems (October 26, 2009)
Synthes USA Recalls Ti Synex II Vertebral Body Replacement (VBR) (November 12, 2009)

T

Teleflex Medical Recalls Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons (February 15, 2009)
Tri-State Hospital Supply Corporation Recalls Centurion Trays and Kits (April 3, 2009)

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Welch Allyn Recalls AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED (April 14, 2009)

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ZOLL Medical Corporation Recalls ZOLL AED Plus Defibrillator (April 8, 2009)

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