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    First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor. First Aid Only, Inc. Vancouver, WA

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·August 17, 2006

    First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include: Labeled with First Aid Only, Inc. Vancouver, WA: Recreational Sports First Aid, Item SM-134; Welder's First Aid Kit, Item 253-U; Vehicle First Aid Kit, Item 220-0; On-The-Road Auto First Aid, Item FAO-310; Auto First Aid Essentials, Item FAO-340; Auto First Aid Essentials, Item FDA-532; Auto First Aid Essentials, Item FDA-552; Vehicle First Aid Kit, Item 221-U; Outdoor First Aid Kit, Item FAO-410; Outdoor First Aid Kit, Item FAO-410 Outdoor First Aid Kit, Item FAO-420; Outdoor First Aid Kit, Item FAO-430; Outdoor First Aid Kit, Item FAO-440; First Aid & Survival Kit, Item FA-462; First Aid Kit, FAO-422-06; First Aid Kit, 403-PC; First Aid Response Kit, FA-504; All Purpose First Aid Kit, Item FAO-112; All Purpose First Aid Kit, Item FAO-122; All Purpose First Aid Kit, Item FAO-142; All Purpose First Aid Kit, Item FAO-432; All Purpose First Aid Kit, Item FAO-444; All Purpose First Aid Kit, Item FAO-452; First Aid Essentials, Item FAO-130; First Aid Essentials, Item FAO-132; First Aid Essentials, Item FAO-134; First Aid Essentials, Item FAO-422; First Aid Essentials, Item FAO-428; First Aid Essentials, Item FAO-432; First Aid Essentials, Item FAO-442; Refillable First Aid Kit, FAO-490C; Refillable First Aid Kit, FAO-490C; Brite Stock first aid kits (only labeled on shipping case as being manufactured by First Aid Only): Item FAO-130-BS; Item FAO-132-BS; Item FAO-134-BS; Manufactured by First Aid Only, Inc. Vancouver, WA. Distributed by Wholesale Merchandisers, Inc., Grand Rapids, MI 49544: Lake & Trail Outdoor First Aid Kit, Item MJR-420; Lake & Trail Outdoor First Aid Kit, Item MJR440; First aid kits labeled DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544: meijer First Aid Kit, Item MJR-130; meijer First Aid Kit, Item MJR-442; First Aid Kits labeled FIRST AID Exchange: General Purpose Home First Aid Kit, Item 2800; Auto First Aid Kit, Item 2825 First Aid Kit labeled Distributed by Medicine Shoppe International St. Louis, MO: All purpose First Aid Kit, Item FAO-132-MS First Aid Kit labeled Mfg. by First Aid Only, Inc. Vancouver, WA Ready Solutions: First Aid Kit, Item 90030 First Aid Kit labeled NORTHERN Safety Co., Inc.: First Aid Kit, Item FAO-442-NS First Aid Kit labeled Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30060: Grafco First Aid Kit, Item 1799-9133 and First Aid Kit labeled -Provided by MOTURIS LTD- Custom Kit, Item 9099

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

    ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

    FDA Enforcement
    Class II ·Terminated·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)·July 6, 2022

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·August 26, 2015

    Radiofrequency Grounding Pad, REF RF-DGP-L

    FDA Recall
    Terminated ·Abbott Medical·Product code GXD·October 14, 2019

    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

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CBI·June 1, 2015

    Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BSR·December 2, 2011

    Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012

    Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012

    Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral constriction and relieve BPH voiding symptoms. The Prostiva RF Therapy System consists of the following major components: " Radio Frequency Generator " Hand Piece Kit " Telescope The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components: " One sterile Hand Piece with radio frequency cable (Model 8929) " One sterile Tubing System (Model 6101) " One non-sterile Return Electrode (Model 8934) The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent).

    FDA Enforcement
    Class II ·Terminated·Urologix, Inc.·November 20, 2013

    10 ga ARS Decompression Needle, Part Number ZZ-0298

    FDA Recall
    Terminated ·North American Rescue LLC.·Product code GAA·August 27, 2021

    First Aid kits, Pharmacist''s Choice, containing acetaminophen and a variety of first aid items, all purpose first aid kit.

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·August 17, 2006

    First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Made in U.S.A. for 3M 3M Consumer Health Care St. Paul, MN 55144-1000

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·August 17, 2006

    Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral constriction and relieve BPH voiding symptoms. The Prostiva RF Therapy System consists of the following major components: " Radio Frequency Generator " Hand Piece Kit " Telescope The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components: " One sterile Hand Piece with radio frequency cable (Model 8929) " One sterile Tubing System (Model 6101) " One non-sterile Return Electrode (Model 8934) The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent).

    FDA Recall
    Terminated ·Urologix, Inc.·Product code GEI·October 21, 2013

    OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·July 25, 2012

    UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

    FDA Enforcement
    Class II ·Terminated·Unistrip Technologies LLC·December 31, 2014

    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.

    FDA Enforcement
    Class III ·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 24, 2014

    3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 28, 2016