BEUDAMED
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    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GAO·February 11, 2015

    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

    Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·NEOSTEO·August 18, 2021

    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

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Enforcement
    Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Enforcement
    Class II ·Terminated·Linde Gas North America Llc·June 26, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    FDA Recall
    Terminated ·LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel·Product code NBW·August 29, 2019

    BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GAA·August 24, 2010

    REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILE After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code GAB·March 10, 2011

    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code GAB·April 24, 2018

    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code GAB·April 24, 2018

    Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GAA·September 1, 2009

    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code GAB·April 24, 2018

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code GAA·October 5, 2020

    SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.

    FDA Recall
    Terminated ·SpineNet·Product code GAA·February 4, 2013

    TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code GAA·October 5, 2020