BEUDAMED
    96 results · 32ms · Sources: EU EUDAMED, US FDA

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    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 Enforcement
    Class II ·Terminated·CME America LLC·November 4, 2020

    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

    CMExpress Microbore Sets, REF: A120-160CYFRV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A120-160XSFK

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    CMExpress Microbore Sets, REF: A120-161C

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A120-161XPSV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    CMExpress Microbore Set, REF: A120-160CRV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A120-003XS2YV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    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

    BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·January 14, 2020

    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

    FDA Recall
    Terminated ·CME America, LLC·Product code FRN·September 16, 2019

    BodyGuard Microset, REF: A100-163XESV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A120-160XPS

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset with Filter, REF: A120-160XSFE

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    Standard BodySet with Needleless Connectors, REF: A120-125XS

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    BodyGuard Microset, REF: A100-163XSL

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020

    CMExpress Microbore Set, REF: A120-161CYF

    FDA Recall
    Terminated ·CME America, LLC·Product code FPA·June 16, 2020