BEUDAMED
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    Boston Scientific IQ Guide Wire. Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack. Catalog No. 38950-02J2, 300 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQX·May 30, 2006

    Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-01J0, 185 cm, J-Tip, Single Pack. Catalog No. 38951-01J2, 185 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQX·May 30, 2006

    The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device.

    FDA Recall
    Terminated ·Heartport, Inc. Route·Product code DWZ·April 12, 2005

    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Recall
    Terminated ·Arcos, Inc·Product code PDT·March 16, 2015

    Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQX·May 30, 2006

    Medex 3000 Series Syringe Infusion Pumps

    FDA Recall
    Terminated ·Medex Inc·Product code CAJ·February 16, 2004

    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CFJ·June 12, 2013

    Advia Chemistry Assay: Lactate

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016

    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CFJ·May 7, 2015

    Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFJ·April 3, 2017

    Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, ''VX in the suffix means it is an evaluation pump, ''NFHU is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software. They are refurbished or upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.

    FDA Recall
    Terminated ·Medex Inc·Product code CAJ·June 9, 2003

    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

    FDA Recall
    Terminated ·Medtest Holdings, Inc.·Product code CFJ·July 8, 2011

    Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CFJ·August 11, 2020

    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CFJ·August 11, 2020

    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K2054, Mat. No. 10464323

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·October 11, 2018

    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018