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

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    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

    FDA Recall
    Open, Classified ·Neotract Inc·Product code PEW·June 24, 2022

    Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022

    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022

    Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022

    Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022

    Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022

    Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022

    PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code GBX·February 12, 2021

    Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code BSP·October 11, 2019

    (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code BZO·April 11, 2022

    Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code BSP·October 11, 2019

    Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code KDQ·June 30, 2020

    RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code CCW·February 18, 2021

    Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code KDQ·June 30, 2020

    (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.

    FDA Recall
    Open, Classified ·TELEFLEX MEDICAL INC·Product code BYD·April 11, 2022