BEUDAMED
    21 results · 44ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FRN·June 14, 2016

    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FRN·June 14, 2016

    Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is intended to be used as a reservoir and fluid path for administering intravenous, subcutaneous, arterial, enteral, and epidural infusions of antibiotics, analgesics, chemotherapeutic agents, and other medications or fluids. Please note that the WalkMed 350VL pump is contraindicated for: Infusion of blood and blood products, Infusion of insulin, Infusion of critical medications whose stoppage or interruption would cause serious injury or death Use in ambulatory regimens by patients who do not possess the mental, physical, or emotional capability to operate the pump properly; or who are not under the care of a responsible individual.

    FDA Recall
    Terminated ·WalkMed, LLC·Product code FRN·September 27, 2017

    T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FRN·October 1, 2015

    T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.

    FDA Recall
    Terminated ·Walkmed Infusion LLC·Product code FRN·June 17, 2010

    Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FPA·June 14, 2016

    Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.

    FDA Recall
    Terminated ·WalkMed Infusion, LLC·Product code FRN·February 17, 2014