BEUDAMED
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    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGL·August 11, 2008

    CCX Operating Software , Version 4.08

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

    Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·November 11, 2020

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 4, 2004

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IWZ·July 16, 2014

    Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·May 4, 2011

    First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CIX·March 10, 2010