BEUDAMED
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    BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·January 16, 2015

    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

    FDA Recall
    Terminated ·Alung Technologies Inc·Product code QLN·December 18, 2020

    STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00 Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00

    FDA Recall
    Terminated ·CME America LLC·Product code FRN·February 27, 2020

    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·January 7, 2020

    CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model: 32.Z2000.00, 32.Z2002.00, 32.Z2004.00, 32.Z2006.00, 32.Z2007.00, 32.Z2008.00, 32.Z2009.00, 32.Z2020.00, 32.Z2022.00, 32.Z2024.00, 32.Z2026.00, 32.Z2027.00, 32.Z2028.00, 32.Z2030.00, 32.Z2032.00, 32.Z2034.00, 32.Z2036.00, 32.Z2038.00, 32.Z2040.00, 72.T1950.00, 72.T1951.00, 72.T1952.00, 72.T1953.00

    FDA Recall
    Terminated ·Omnia SRL Via Fratelli Cairoli 5 Fidenza Italy·Product code EME·March 30, 2021

    Thermoflect Product Line including items for adults and pediatrics.

    FDA Recall
    Terminated ·Encompass Group LLC·Product code FME·December 23, 2009

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·July 30, 2020

    CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·July 30, 2020

    CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·July 30, 2020

    CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·July 30, 2020

    CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·July 30, 2020

    HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

    FDA Recall
    Terminated ·Hach Co·Product code LIF·April 21, 2009

    CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·July 30, 2020

    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

    HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. The firm name on the label is HACH Company, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.

    FDA Recall
    Terminated ·Hach Co·Product code FKP·May 23, 2008

    HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.

    FDA Recall
    Terminated ·Hach Co·Product code FKP·May 23, 2008