BEUDAMED
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    Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JJE·March 21, 2017

    Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing 504 tips) and 235400 (case containing 20 boxes), Manufactured by Hamilton Company, Reno, Nevada

    FDA Recall
    Terminated ·Hamilton Co·Product code -JTC·January 30, 2007

    Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·February 25, 2005

    Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·June 8, 2005

    Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, Catalog 45-333, Material #M001453330. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·June 8, 2005

    Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·February 25, 2005

    Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·June 8, 2005

    Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LLD·February 25, 2005

    Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IKD·February 22, 2019

    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in 2106381-005 ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-001 ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in 2106383-002 ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in 2106383-003 ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in 2106383-004 ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in 2106383-005 ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-006 ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106385-001 ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in 2106385-002 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN 2106385-003 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN 2106385-004 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN 2106394-003 ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in 2106395-001 ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in 2106396-001 ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in 2106396-002 ECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSA·May 10, 2019

    Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/O2/IP/TP/BATT ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200 II 3LD/RSP/SP02 MDD MEDEXL. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit: Medium Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated, 60'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004