BEUDAMED
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    First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·December 10, 2007

    Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100

    FDA Recall
    Terminated ·First Aid Only Inc·Product code GAA41·December 10, 2007

    AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN

    FDA Recall
    Terminated ·American Medical Systems·Product code FAE·February 19, 2007

    Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FAE·April 9, 2015

    AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN

    FDA Recall
    Terminated ·American Medical Systems·Product code FAE·February 19, 2007

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Recall
    Terminated ·Miami Fat Supply, Inc·Product code MUU·April 21, 2016

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Enforcement
    Class II ·Terminated·Miami Fat Supply, Inc·June 22, 2016

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 12, 2021

    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·April 26, 2011

    ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·June 7, 2011

    Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code FAD·March 1, 2006

    KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·January 14, 2011

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·November 2, 2012

    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code CAE·June 29, 2016

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070024-14-13; GPN REF G18125. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008