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    CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan Dx Pre-PCR (-20C) MOD T E W, CytoScan Dx Pre-PCR (2-8C) MOD F L H, CytoScan Dx Post-PCR (-20C) MOD S AH W PB, CytoScan Dx Post-PCR (2-8C) MOD E PW, CytoScan Dx Post-PCR (15- 30 C) CytoScan Dx WS A CytoScan Dx WS B CytoScan Dx Array kit, 6Pk ChAS Dx Analysis Software and Browser

    FDA Recall
    Terminated ·Affymetrix Inc·Product code PFX·April 14, 2016

    Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LJS·September 15, 2005

    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

    ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code FJS·October 20, 2014

    Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number: 73386 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code FPX·July 18, 2013

    Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FFX·February 23, 2009

    AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

    FDA Recall
    Terminated ·Sierra Scientific Instruments Inc·Product code FFX·October 12, 2011

    Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

    FDA Recall
    Terminated ·Medtronic Gastroenterology Urology·Product code FFX·April 28, 2004

    Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item Number: 73386-01 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK Item Number: 73192 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011